AGENCY:
Food and Drug Administration, Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
DATES:
Approval is withdrawn as of November 22, 2021.
FOR FURTHER INFORMATION CONTACT:
James Hanratty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-4718, James.Hanratty@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The holders of an approved application to market a new drug for human use are required to submit annual reports to FDA concerning their approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). In the Federal Register of January 9, 2020 (85 FR 1160), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 249 ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports for those ANDAs (“Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing”). The holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the NOOH and requested a hearing. The remaining holders of those ANDAs did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders of the ANDAs not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the 216 applications listed in table 1.
85 FR 1160, published on January 9, 2020, incorrectly listed 249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR 1160 listed 248 ANDAs in the table included in the notice.
I. Annual Reports Submitted
In response to the NOOH, one firm requested a hearing and had previously submitted an annual report for each of its three ANDAs. Therefore, FDA rescinds its proposal to withdraw approval of the following three ANDAs:
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920:
- ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50 milligrams (mg)
- ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg
- ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg
Another three firms notified the Agency that they had submitted an annual report for each of its ANDAs listed in the NOOH. Therefore, FDA rescinds its proposal to withdraw approval of the following eight ANDAs:
Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716:
- ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base
- ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base
- ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg
- ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/400 mg
MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm. PS049, Stanford, CA 94305:
- ANDA 204472, FLUDEOXYGLUCOSE F-18 Injection USP, 20-300 millicuries (mCi)/milliliters (mL)
- ANDA 204517, SODIUM FLUORIDE F-18 Injection, 10-200 mCi/mL
- ANDA 204535, AMMONIA N-13 Injection USP, 3.75-37.5 mCi/mL
Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631:
- ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg
II. Previously Consolidated Application
Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously been consolidated with ANDA 088072. Therefore, FDA rescinds its proposal to withdraw approval of this ANDA.
III. Previously Transferred Application
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that ANDA 060074, PENICILLIN G POTASSIUM for Injection, 20,000,000 units/vial, had previously been transferred to Cultor Food Science, Inc. Therefore, FDA rescinds its proposal to withdraw approval of this ANDA.
IV. Requests To Withdraw Approval
In response to the NOOH, 13 firms notified the Agency that they no longer market 15 of the ANDAs listed in the NOOH and had previously submitted written requests for withdrawal for the following ANDAs:
1. Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620, notified the Agency that they no longer market the product for ANDA 060521, HUMATIN (paromomycin sulfate) Capsules USP, Equivalent to (EQ) 250 mg base. On May 12, 2021 (86 FR 26058), the Agency withdrew approval of this ANDA at the written request of the applicant.
2. Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the product for ANDA 060709, OLEANDOMYCIN Injection. On July 21, 2020 (85 FR 44096), the Agency withdrew approval of this ANDA under the written request of the applicant.
3. Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001, notified the Agency that they no longer market the product for ANDA 061034, LINCOMYCIN HYDROCHLORIDE (HCl) Powder. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
4. Lederle Laboratories, Division of American Cyanamid Co., 401 North Middletown Rd., Pearl River, NY 10965, notified the Agency that they no longer market the product for ANDA 061064, NYSTATIN Ointment. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
5. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the product for ANDA 061087, BENZOCAINE, OXYTETRACYCLINE HCl, and POLYMYXIN B SULFATE OTIC Solution. On July 21, 2020, the Agency withdrew approval of this ANDA under the written request of the applicant.
6. Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950, notified the Agency that they no longer market the product for ANDA 061652, OXYTETRACYCLINE Capsules. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
7. AH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220, notified the Agency that they no longer market the product for ANDA 061701, TETRACYCLINE Syrup, 125 mg/5 mL. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
8. Warner Chilcott, Division of Warner Lambert-Pfizer, Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the products for ANDA 061725, TETRACYCLINE HCl Capsules, 250 mg and 500 mg, and ANDA 062175, TETRACYCLINE HCl Capsules, 250 mg. On July 21, 2020, the Agency withdrew approval of these ANDAs under the written request of the applicant.
9. Lederle Laboratories, Division of American Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470, notified the Agency that they no longer market the products for ANDA 061943, CHLORAMPHENICOL Ophthalmic Solution, 0.5 percent; ANDA 062215, OXYTETRACYCLINE HCl Capsules. On July 21, 2020, the Agency withdrew approval of these ANDAs under the written request of the applicant.
10. Warner-Lambert Co. notified the Agency that they no longer market the product for ANDA 062032, EYPAR (erythromycin stearate) Tablets, EQ 250 mg base and EQ 500 mg base. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
11. Becton Dickinson and Co., Surgical System, 9450 South State St., Sandy, UT 84070, notified the Agency that they no longer market the product for ANDA 073416, E-Z SCRUB (chlorhexidine gluconate) Topical Sponge, 4 percent. On January 8, 2020 (85 FR 909), the Agency withdrew approval of this ANDA under the written request of the applicant.
12. Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215, notified the Agency that they no longer market the products for ANDA 083001, TRIAMCINOLONE ACETONIDE Aerosol Foam Emulsion. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
13. Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215, notified the Agency that they no longer market the product for ANDA 084803, CHLORPROMAZINE HCl Tablets, 10 mg. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.
V. Previously Withdrawn Applications
In the Federal Register of September 25, 2020 (85 FR 60474), FDA published a separate notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy for the following ANDAs:
1. Everylife, 2021 15th Avenue West, Seattle, WA 98119: ANDA 085217, ACETAMINOPHEN and CODEINE PHOSPHATE Tablet, 325 mg/30 mg.
2. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX 75093: ANDA 085638, ACETAMINOPHEN, ASPIRIN, and CODEINE, 150 mg/180 mg/60 mg; ANDA 085639, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE Capsule, 150 mg/180 mg/30 mg; ANDA 085640, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE Capsule, 150 mg/180 mg/15 mg.
The holders of the applications did not respond to the Federal Register NOOH of September 25, 2020. Failure to submit a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. On April 9, 2021 (86 FR 18542), the Agency withdrew approval of these ANDAs.
VI. No Response to NOOH Received
The holders of the other 216 applications did not respond to the NOOH. Failure to submit a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, the Director, Center for Drug Evaluation and Research, is withdrawing approval of the 216 applications listed in table 1.
Table 1—Approved ANDAs for Which Required Reports Have Not Been Submitted
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 020374 | Inpersol-LC/LM with Dextrose 1.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 1.5 grams (g)/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL | Fresenius USA, Inc., 2637 Shadelands Dr., Walnut Creek, CA 94598. |
| Inpersol-LC/LM with Dextrose 2.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL | ||
| Inpersol-LC/LM with Dextrose 3.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 3.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL | ||
| Inpersol-LC/LM with Dextrose 4.25% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL | ||
| ANDA 040057 | Epinephrine and Lidocaine Hydrochloride (HCl) Injection, 0.01 mg/mL; 2% and 0.02 mg/mL; 2% | Eastman Kodak Co., 343 State St., Rochester, NY 14650. |
| ANDA 040168 | Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2% | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 West Main St., Morton Grove, IL 60053. |
| ANDA 040192 | Prednisolone Syrup, 15 mg/5 mL | WE Pharmaceuticals, Inc., 1142 D St., P.O. Box 1142, Ramona, CA 92065. |
| ANDA 060131 | Tetracycline HCl Capsules | Leiner Health Products, Inc., 901 East 233rd St., Carson, CA 90745. |
| ANDA 060461 | Neomycin Sulfate Ointment; Neomycin Sulfate and Hydrocortisone Acetate Ointment | Ambix Laboratories, Division of Organics Corp. of America, 210 Orchard St., East Rutherford, NJ 07073. |
| ANDA 060602 | Penicillin G Potassium Powder | John D. Copanos and Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225. |
| ANDA 060627 | Tribiotic (polymyxin B sulfate, bacitracin, and neomycin sulfate) Ointment, 5000 units/400 units/5 mg | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 060724 | Pyocidin-HC (neomycin sulfate, polymyxin B sulfate, and hydrocortisone) Otic Solution | Kasco-EFCO Laboratories, Inc., Cantiague Rock Rd., Hicksville, NY 11802. |
| ANDA 060769 | Tetracycline Syrup | West-Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ 07724. |
| ANDA 060773 | Tetracycline Syrup | Leiner Health Products, Inc. |
| ANDA 060870 | Oxytetracycline Injection | Proter S.p.A., c/o Richmar International, Inc., 1706 Birch Rd., McLean, VA 22101. |
| ANDA 061154 | Hydrocortisone Acetate and Neomycin Sulfate Ointment | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 061209 | Bacitracin Ointment USP, 500 units/g | Do. |
| ANDA 061228 | Griseofulvin Capsules | Owen Laboratories, Division of Alcon Laboratories, 3737 Beltline Rd., Dallas, TX 75234. |
| ANDA 061483 | Penicillin G Potassium Tablets | Leiner Health Products, Inc. |
| ANDA 061518 | Bacitracin Zinc Ointment | Rexall Drug Co., 135 Chesterfield Industrial Blvd., Chesterfield, MO 63017. |
| ANDA 061519 | Bacitracin Zinc and Neomycin Sulfate Ointment | Do. |
| ANDA 061520 | Bacitracin Zinc and Neomycin Sulfate/Polymyxin B Sulfate Ointment | Do. |
| ANDA 061521 | Bacitracin Zinc, Benzocaine, and Neomycin Sulfate/Polymyxin B Sulfate Ointment | Do. |
| ANDA 061528 | Penicillin V Potassium Tablets USP, EQ 250 mg base and EQ 500 mg base | American Antibiotics, Inc., 6110 Robinwood Rd., Baltimore, MD 21225. |
| ANDA 061529 | Penicillin V Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | Do. |
| ANDA 061532 | Ampicillin Trihydrate Capsules | Leiner Health Products, Inc. |
| ANDA 061601 | Ampicillin for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | American Antibiotics, Inc. |
| ANDA 061602 | Ampicillin Capsules USP, EQ 250 mg base and EQ 500 mg base | Do. |
| ANDA 061632 | Ampicillin Trihydrate Capsules, 250 mg | Chromalloy Pharmaceuticals, Inc., 5353 Grosvenor Blvd., Los Angeles, CA 90066. |
| ANDA 061674 | Penicillin V Potassium Tablets | Leiner Health Products, Inc. |
| ANDA 061697 | Griseofulvin Capsules | Watson Laboratories, Inc., 311 Bonnie Cir., Corona, CA 92880. |
| ANDA 061699 | Bacitracin Powder for Rx Compounding, 5,000,000 units/bottle | Apothekernes Laboratorium A.S., c/o AL Laboratories, Inc., 1 Executive Dr., Fort Lee, NJ 07024. |
| ANDA 061833 | Oxytetracycline HCl Capsules, 250 mg | Pliva, c/o Transtrade USA, Ltd., 515 Madison Ave., 4th Floor East, New York, NY 10022. |
| ANDA 061847 | Bleomycin Sulfate Injection | Takasaki Plant, Nippon Kayaku Co., Ltd., 500 5th Ave., Suite 1726, New York, NY 10110. |
| ANDA 061857 | Penicillamine Powder | Chemiewerk Homberg, c/o Wallace Laboratories, Cranbury, NJ 08512. |
| ANDA 061903 | Bacitracin Zinc and Polymyxin B Sulfate Ointment | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 062085 | Tetracycline HCl Capsules, 250 mg | MM Mast and Co., 4152 Ruple Rd., Cleveland, OH 44121. |
| ANDA 062205 | Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base | Ceph International Corp. c/o Mova Pharmaceutical Corp., State Rd. #1, Jose Garrido St., Cagus, PR 00725. |
| ANDA 062340 | Gentamicin Sulfate Injection | Pharmaceutical Specialist Association, 9852 Cowden St., Philadelphia, PA 19115. |
| ANDA 062467 | E-Solve 2 (erythromycin) Lotion, 2% | Syosset Laboratories, Inc., 150 Eileen Way, Syosset, NY 11791. |
| ANDA 062758 | Eryzole (erythromycin ethylsuccinate and sulfisoxazole acetyl) Granules, EQ 200 mg base/5 mL; EQ 600 mg base/5 mL | Alra Laboratories, Inc., 3850 Clearview Ct., Gurnee, IL 60031. |
| ANDA 062944 | Clindamycin Phosphate Topical Solution USP, EQ 1% base | BOCA Pharmacal, LLC., 3550 North West 126th Ave., Coral Springs, FL 33065. |
| ANDA 070104 | Chlorhexidine Gluconate Topical Solution, 4% | Matrix Medical Corp., 1825 South 3730 West, Salt Lake City, UT 84104. |
| ANDA 071054 | Constilac (lactulose) Solution, 10 g/15 mL | Alra Laboratories, Inc. |
| ANDA 071057 | Ibu-tab 200 (ibuprofen) Tablets, 200 mg | Do. |
| ANDA 071058 | Ibu-tab (ibuprofen) Tablets, 400 mg | Do. |
| ANDA 071059 | Ibu-tab (ibuprofen) Tablets, 600 mg | Do. |
| ANDA 071104 | Leucovorin Calcium Tablets, EQ 15 mg base | Xanodyne Pharmacal, Inc., 7310 Turfway Rd., Suite 490, Florence, KY 41042. |
| ANDA 071139 | Trazodone HCl Tablets, 50 mg | American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716. |
| ANDA 071140 | Trazodone HCl Tablets, 100 mg | Do. |
| ANDA 071331 | Cholac (lactulose) Solution, 10 g/15 mL | Alra Laboratories, Inc. |
| ANDA 071362 | Meclofenamate Sodium Capsules USP, 50 mg | American Therapeutics, Inc. |
| ANDA 071363 | Meclofenamate Sodium Capsules USP, 100 mg | Do. |
| ANDA 071419 | Brian Care (chlorhexidine gluconate) Topical Solution, 4% | Soapco, Inc., P.O. Box 5490, Pleasanton, CA 94566. |
| ANDA 071429 | Clorazepate Dipotassium Capsules, 3.75 mg | American Therapeutics, Inc. |
| ANDA 071430 | Clorazepate Dipotassium Capsules, 7.5 mg | Do. |
| ANDA 071431 | Clorazepate Dipotassium Capsules, 15 mg | Do. |
| ANDA 071569 | Danazol Capsules USP, 200 mg | Do. |
| ANDA 071787 | Gen-Xene (clorazepate dipotassium) Tablets, 3.75 mg | Alra Laboratories, Inc. |
| ANDA 071788 | Gen-Xene (clorazepate dipotassium) Tablets, 7.5 mg | Do. |
| ANDA 071789 | Gen-Xene (clorazepate dipotassium) Tablets, 15 mg | Do. |
| ANDA 071955 | Oxazepam Capsules USP, 10 mg | American Therapeutics, Inc. |
| ANDA 071956 | Oxazepam Capsules USP, 15 mg | Do. |
| ANDA 071957 | Oxazepam Capsules USP, 30 mg | Do. |
| ANDA 071962 | Leucovorin Calcium Tablets, EQ 10 mg base | Xanodyne Pharmacal, Inc. |
| ANDA 071965 | Ibu-tab (ibuprofen) Tablets, 800 mg | Alra Laboratories, Inc. |
| ANDA 072022 | Triamterene and Hydrochlorothiazide Tablets, 75 mg/50 mg | American Therapeutics, Inc. |
| ANDA 072129 | Maprotiline HCl Tablets USP, 25 mg | Do. |
| ANDA 072130 | Maprotiline HCl Tablets USP, 50 mg | Do. |
| ANDA 072131 | Maprotiline HCl Tablets USP, 75 mg | Do. |
| ANDA 072190 | Metaproterenol Sulfate Inhalation Solution, 5% | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 072255 | Microderm (chlorhexidine gluconate) Topical Solution, 4% | Johnson and Johnson Medical, Inc., 2500 Arbrook Blvd., Arlington, TX 76014. |
| ANDA 072292 | Prevacare R (chlorhexidine gluconate) Topical Solution, 0.5% | Do. |
| ANDA 072295 | Microderm (chlorhexidine gluconate) Topical Sponge, 4% | Do. |
| ANDA 072307 | Fenoprofen Calcium Capsules USP, 200 mg | American Therapeutics, Inc. |
| ANDA 072308 | Fenoprofen Calcium Capsules USP, 300 mg | Do. |
| ANDA 072309 | Fenoprofen Calcium Tablets USP, 600 mg | Do. |
| ANDA 072782 | Prazosin HCl Capsules USP, 1 mg | Do. |
| ANDA 072783 | Prazosin HCl Capsules USP, 2 mg | Do. |
| ANDA 072784 | Prazosin HCl Capsules USP, 5 mg | Do. |
| ANDA 073535 | Piroxicam Capsules, 10 mg | Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. |
| ANDA 074523 | Metromidol (metronidazole) Tablets, 250 mg and 500 mg | Laboratorios Applicaciones Farmaceuticas S.A. de CV, c/o Richard Hamer Association, Inc., P.O. Box 16598, Fort Worth, TX 76162. |
| ANDA 074560 | Flurbiprofen Tablets USP, 100 mg | Theragen, Inc., 10 Lake Dr., East Windsor, NJ 08520. |
| ANDA 074702 | Metaproterenol Sulfate Syrup, 10 mg/5 mL | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 074881 | Iopamidol Injection, 41%, 51%, 61%, and 76% | Cook Imaging Corp., 927 South Curry Pike, P.O. Box 3068, Bloomington, IN 47403. |
| ANDA 075181 | Prednisolone Sodium Phosphate Oral Solution, EQ 5 mg base/5 mL | WE Pharmaceuticals, Inc. |
| ANDA 075260 | Tretinoin Topical Solution, 0.05% | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 075414 | Nifedipine Extended-Release Tablets, 90 mg | Martec USA, LLC, 1800 North Topping Ave., Kansas City, MO 64120. |
| ANDA 075507 | Ipratropium Bromide Inhalation Solution, 0.02% | Pharmascience, Inc., 10 Orchard Pl., Tenafly City, NJ 07670. |
| ANDA 075569 | Thallous Chloride TL 201 Injection USP, 1 mCi/mL | Trace Life Sciences, Inc., 2101 Shady Oaks, Denton, TX 76205. |
| ANDA 075586 | Metaproterenol Sulfate Inhalation Solution, 0.4% and 0.6% | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 075619 | Minoxidil Extra Strength (for Men) Topical Solution, 5% | Avacor Products, LLC, 227 East 56th St., 3rd Floor, New York, NY 10022. |
| ANDA 075766 | Calcitriol Injection, 1 microgram (mcg)/mL and 2 mcg/mL | Fresenius Medical Care North America, 95 Hayden Ave., Lexington, MA 02421. |
| ANDA 075941 | Strontium Chloride SR-89 Injection, 1 mCi/mL | Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103. |
| ANDA 077072 | Ipratropium Bromide Inhalation Solution, 0.02% | Landela Pharmaceutical, 776 East Riverside Dr., Suite 150, Eagle, ID 83616. |
| ANDA 077218 | ThyroShield (potassium iodide) Oral Solution USP, 65 mg/mL | Arco Pharmaceuticals, LLC, 7605 Maryland Ave., St. Louis, MO 63105. |
| ANDA 077569 | Albuterol Sulfate Inhalation Solution, EQ 0.083% base | Landela Pharmaceutical. |
| ANDA 080024 | Sulfacel-15 (sulfacetamide sodium) Ophthalmic Solution, 15% | Optopics Laboratories Corp., P.O. Box 210, Fairton, NJ 08320. |
| ANDA 080036 | Sosol (sulfisoxazole) Tablets, 500 mg | MK Laboratories, Inc., 424 Grasmere Ave., Fairfield, CT 06430. |
| ANDA 080366 | Soxazole (sulfisoxazole) Tablets, 500 mg | Alra Laboratories, Inc. |
| ANDA 080380 | Bamate (meprobamate) Tablets, 200 mg and 400 mg | Do. |
| ANDA 080483 | Hi-cor (hydrocortisone) Cream, 2.5% | C and M Pharmacal, Inc., 1519 East 8 Mile Rd., Hazel Park, MI 48030. |
| ANDA 080492 | Reserpine Tablets, 0.1 mg and 0.25 mg | Marshall Pharmacal Corp., 89 Michael St., South Hackensack, NJ 07606. |
| ANDA 080518 | Dimenhydrinate Tablets, 50 mg | Alra Laboratories, Inc. |
| ANDA 080519 | Diphenhydramine HCl Capsules, 25 mg and 50 mg | Do. |
| ANDA 080525 | Reserpine Tablets, 0.1 mg and 0.25 mg | MK Laboratories, Inc. |
| ANDA 080592 | Diphenhydramine HCl Capsules, 50 mg | Valeant Pharmaceuticals International, One Enterprise, Aliso Viejo, CA 92656. |
| ANDA 080660 | Ocusulf (sulfacetamide sodium) Ophthalmic Solution, 10% and 30% | Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories, 40 Main St., P.O. Box 210, Fairton, NJ 08320. |
| ANDA 080714 | Diphenhydramine HCl Oral Solution, 12.5 mg/5 mL | Alra Laboratories, Inc. |
| ANDA 080715 | Dimenhydrinate Oral Solution, 12.5 mg/4 mL | Do. |
| ANDA 080941 | Isoniazid Tablets, 100 mg | MK Laboratories, Inc. |
| ANDA 080970 | Methscopolamine Bromide Tablets, 2.5 mg | Private Formulations, Inc., 460 Plainfield Ave., Edison, NJ 08818. |
| ANDA 083087 | Diphenhydramine HCl Capsules, 25 mg and 50 mg | MK Laboratories, Inc. |
| ANDA 083088 | Diphenhydramine HCl Elixir, 12.5 mg/5 mL | Do. |
| ANDA 083264 | Pentobarbital Sodium Capsules, 100 mg | Valeant Pharmaceuticals International. |
| ANDA 083286 | Chlorpheniramine Maleate Tablets | Marshall Pharmacal Corp. |
| ANDA 083315 | Procaine HCl Injection, 1% and 2% | Elkins Sinn Pharmaceutical Co., c/o ESI Lederle, 2 Esterbrook Ln., Cherry Hill, NJ 08003. |
| ANDA 083320 | Acetazolamide Tablets, 250 mg | Alra Laboratories, Inc. |
| ANDA 083389 | Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 1% | Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666. |
| ANDA 083390 | Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 2% | Do. |
| ANDA 083457 | Vitamin A Palmitate Capsules, EQ 25,000 units base and EQ 50,000 units base | MK Laboratories, Inc. |
| ANDA 083524 | Butabarbital Sodium Tablets, 16.2 mg | Marshall Pharmacal Corp. |
| ANDA 083525 | Niacin Tablets, 500 mg | MK Laboratories, Inc. |
| ANDA 083526 | Folic Acid Tablets, 1 mg | Do. |
| ANDA 083658 | Promethazine HCl Tablets, 25 mg | Private Formulations, Inc. |
| ANDA 083806 | Dexamethasone Tablets, 0.75 mg | Phoenix Laboratories, Inc., 175 Lauman Ln., East Hicksville, NY 11801. |
| ANDA 083827 | Pramine (imipramine HCl) Tablets, 10 mg, 25 mg, and 50 mg | Alra Laboratories, Inc. |
| ANDA 083858 | Butabarbital Sodium Tablets, 32.4 mg | Marshall Pharmacal Corp. |
| ANDA 083863 | Sulfisoxazole Cream | Holland Rantos Co., Inc., P.O. Box 385, Piscataway, NJ 08854. |
| ANDA 084185 | Bethanechol Chloride Tablets, 10 mg | Wendt Laboratories, Inc., 200 West Beaver, P.O. Box 128, Belle Plaine, MN 56011. |
| ANDA 084186 | Bethanechol Chloride Tablets, 25 mg | Do. |
| ANDA 084188 | Myotonachol (bethanechol chloride) Tablets, 5 mg, 10 mg, and 25 mg | Glenwood, Inc., 83 North Summit St., P.O. Box 518, Tenafly, NJ 07670. |
| ANDA 084246 | Cortisone Acetate Tablets, 25 mg | Everylife, 2021 15th Ave., West Seattle, WA 98119. |
| ANDA 084439 | Prednisolone Tablets, 1 mg, 2.5 mg, and 5 mg | Do. |
| ANDA 084440 | Prednisone Tablets, 1 mg, 2.5 mg, and 5 mg | Do. |
| ANDA 084494 | Hydrochlorothiazide Tablets | West-Ward Pharmaceutical Corp. |
| ANDA 084590 | Pentobarbital Sodium Capsules, 100 mg | Anabolic, Inc., 1835 East Cheyenne Rd., Colorado Springs, CO 80905. |
| ANDA 084687 | Niacin Tablets, 500 mg | Zzeon Pharmaceuticals, Ltd., Jamboree at Kevin, Irvine, CA 92705. |
| ANDA 084714 | Hydro-Reserp (hydrochlorothiazide and reserpine) Tablets, 50 mg/0.125 mg | ABC Holding Corp., P.O. Box 307, 70945 Van Dyke Ave., Romeo, MI 48065. |
| ANDA 084729 | Lidocaton (epinephrine and lidocaine HCl) Injection, 0.01 mg/mL and 2% | Pharmaton, Ltd., c/o Bass Ullmna and Lustigman, 747 3rd Ave., New York, NY 10017. |
| ANDA 084872 | Meclizine HCl Tablets, 25 mg | CM Bundy Co., 2055 Reading Rd., Cincinnati, OH 45205. |
| ANDA 084902 | Promethacon (promethazine HCl) Suppository, 50 mg | Polymedica Industries, Inc., 2 Constitution Way, Woburn, MA 01801. |
| ANDA 084931 | Methamphetamine HCl Tablets, 5 mg and 10 mg | Rexar Pharmacal, 396 Rockaway Ave., Valley Stream, NY 11581. |
| ANDA 084933 | Diethylstilbestrol Tablets, 1 mg | West-Ward Pharmaceutical Corp. |
| ANDA 084977 | Halothane Inhalation, 99.99% | BH Chemicals, Inc., 500 5th Ave., New York, NY 10036. |
| ANDA 085009 | Lygen (chlordiazepoxide HCl) Capsules, 10 mg | Alra Laboratories, Inc. |
| ANDA 085039 | Folic Acid Tablets USP, 1 mg | Wendt Laboratories, Inc. |
| ANDA 085040 | Isoniazid Tablets USP, 100 mg | Do. |
| ANDA 085041 | Meclizine HCl Tablets, 25 mg | Do. |
| ANDA 085042 | Methocarbamol Tablets USP, 500 mg | Do. |
| ANDA 085044 | Reserpine Tablets USP, 0.25 mg | Do. |
| ANDA 085075 | Aerolate III (theophylline) Extended-Release Capsules, 65 mg Aerolate JR (theophylline) Extended-Release Capsules, 130 mg Aerolate SR (theophylline) Extended-Release Capsules, 260 mg | Fleming and Co. Pharmaceuticals, Inc., 1600 Fenton Park Dr., Fenton, MO 63026. |
| ANDA 085107 | Lygen (chlordiazepoxide HCl) Capsules, 5 mg | Alra Laboratories, Inc. |
| ANDA 085108 | Lygen (chlordiazepoxide HCl) Capsules, 25 mg | Do. |
| ANDA 085125 | Methyltestosterone Sublingual Tablets, 10 mg | Tablicaps, Inc., P.O. Box 5555, Franklinville, NJ 08322. |
| ANDA 085235 | Chlordiazepoxide HCl Capsules | Abbott Laboratories, Pharmaceutical Products Division, 100 Abbott Park Rd., Abbott Park, IL 60064. |
| ANDA 085236 | Chlordiazepoxide HCl Capsules | Do. |
| ANDA 085252 | Meclizine HCl Tablets, 25 mg | ABC Holding Corp. |
| ANDA 085253 | Meclizine HCl Tablets, 12.5 mg | Do. |
| ANDA 085282 | Hydrocortisone Lotion, 0.5% and 1% | Mericon Industries, Inc., 8819 North Pioneer Rd., Peoria, IL 61615. |
| ANDA 085383 | Butabarbital Sodium Elixir, 30 mg/5 mL | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 085411 | Phentermine HCl Capsules, 30 mg | ABC Holding Corp. |
| ANDA 085511 | Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 085512 | Phenazine-35 (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 085550 | Butabarbital Sodium Tablets, 30 mg | CM Bundy Co. |
| ANDA 085569 | Chlorothiazide Tablets, 250 mg | ABC Holding Corp. |
| ANDA 085587 | Meclizine HCl Chewable Tablets | Camall Co., Inc., 60950 Van Dyke Ave., P.O. Box 218, Washington, MI 48094. |
| ANDA 085672 | Hydrochlorothiazide Tablets, 50 mg | ABC Holding Corp. |
| ANDA 085756 | Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg | Camall Co., Inc. |
| ANDA 085766 | Atropine Sulfate and Diphenoxylate HCl Tablets, 0.025 mg/2.5 mg | Private Formulations, Inc. |
| ANDA 085888 | Brompheniramine Maleate Tablets | Leiner Health Products, Inc. |
| ANDA 085891 | Meclizine HCl Tablets, 25 mg | Anabolic, Inc. |
| ANDA 085895 | Secobarbital Sodium Capsules, 100 mg | Everylife. |
| ANDA 086008 | Hydrocortisone and Urea Cream, 1%/10% | Bioglan Laboratories, Ltd., 450 Hilltop Rd., Riegelsville, PA 18077. |
| ANDA 086077 | Nitrofurazone Ointment, 0.2% | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 086079 | Hydrocortisone Ointment, 1% | Do. |
| ANDA 086080 | Hydrocortisone Cream, 1% | Do. |
| ANDA 086141 | Tolbutamide Tablets, 500 mg | Alra Laboratories, Inc. |
| ANDA 086260 | Ona-Mast (phentermine HCl) Tablets, 8 mg | MM Mast and Co. |
| ANDA 086271 | Hydrocortisone Cream, 2.5% | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 086272 | Hydrocortisone Ointment, 2.5% | Do. |
| ANDA 086498 | Amitriptyline HCl Tablets, 10 mg | Alra Laboratories, Inc. |
| ANDA 086499 | Amitriptyline HCl Tablets, 50 mg | Do. |
| ANDA 086500 | Amitriptyline HCl Tablets, 150 mg | Do. |
| ANDA 086501 | Amitriptyline HCl Tablets, 100 mg | Do. |
| ANDA 086502 | Amitriptyline HCl Tablets, 25 mg | Do. |
| ANDA 086503 | Amitriptyline HCl Tablets, 75 mg | Do. |
| ANDA 086511 | Ona-Mast (phentermine HCl) Capsules, 30 mg | MM Mast and Co. |
| ANDA 086516 | Ona-Mast (phentermine HCl) Capsules, 30 mg | Do. |
| ANDA 086550 | X-Trozine (phendimetrazine tartrate) Tablets, 35 mg | Shire Richwood, Inc., 7900 Tanners Gate Dr., Suite 200, Florence, KY 41042. |
| ANDA 086551 | X-Trozine (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 086552 | X-Trozine (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 086553 | X-Trozine (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 086554 | X-Trozine (phendimetrazine tartrate) Tablets, 35 mg | Do. |
| ANDA 086735 | Phentermine HCl Capsules, 15 mg | Camall Co., Inc. |
| ANDA 086748 | Theophylline Elixir, 80 mg/15 mL | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 086766 | Nitrofurazone Ointment, 0.2% | Wendt Laboratories, Inc. |
| ANDA 087081 | Nitrofurazone Topical Solution, 0.2% | Do. |
| ANDA 087226 | Phentermine HCl Capsules, 30 mg | Camall Co., Inc. |
| ANDA 087371 | X-Trozine L.A. (phendimetrazine tartrate) Extended-Release Capsules, 105 mg | Shire Richwood, Inc. |
| ANDA 087392 | Aminophylline Injection, 25 mg/mL | Pharma Serve, Inc., Subsidiary of Torigian Laboratories, 218-20 98th Ave., Queens Village, NY 11429. |
| ANDA 087394 | X-Trozine (phendimetrazine tartrate) Capsules, 35 mg | Shire Richwood, Inc. |
| ANDA 087442 | Neosar (cyclophosphamide) for Injection, 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial | Bedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146. |
| ANDA 087487 | Melfiat-105 (phendimetrazine tartrate) Extended-Release Capsules, 105 mg | Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837. |
| ANDA 087636 | Tropicamide Ophthalmic Solution, 0.5% | Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories. |
| ANDA 087637 | Tropicamide Ophthalmic Solution, 1% | Do. |
| ANDA 087681 | Paracaine (proparacaine HCl) Ophthalmic Solution, 0.5% | Optopics Laboratories Corp. |
| ANDA 087764 | Oby-Trim (phentermine HCl) Capsules, 30 mg | Shire Richwood, Inc. |
| ANDA 087932 | Triamcinolone Acetonide Cream, 0.025% | Ambix Laboratories, Division of Organics Corp. of America. |
| ANDA 088786 | Sodium Polystyrene Sulfonate USP Powder, 453.6 g/bottle | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
| ANDA 088897 | Promethazine VC Plain (phenylephrine HCl and promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL | Do. |
| ANDA 089141 | Aerolate (theophylline) Oral Solution, 150 mg/15 mL | Fleming and Co. Pharmaceuticals, Inc. |
| ANDA 089417 | Methocarbamol Tablets USP, 500 mg | American Therapeutics, Inc. |
| ANDA 089418 | Methocarbamol Tablets USP, 750 mg | Do. |
| ANDA 089478 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg | Do. |
| ANDA 089479 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg | Do. |
| ANDA 089480 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg | Do. |
| ANDA 089514 | Trihexyphenidyl HCl Elixir, 2 mg/5 mL | Pharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona, NY 10970. |
| ANDA 089726 | Prednisone Oral Solution, 5 mg/5 mL | Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. |
FDA finds that the holders of the ANDAs listed in table 1 have repeatedly failed to submit reports required by §§ 314.81 and 314.98. In addition, under § 314.200, FDA finds that the holders of the ANDAs have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the ANDAs listed in table 1 and all amendments and supplements thereto, is hereby withdrawn, effective October 22, 2021.
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23075 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P