87 FR 132 pgs. 41322-41323 - Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Type: NOTICEVolume: 87Number: 132Pages: 41322 - 41323
Pages: 41322, 41323Docket number: [Docket No. FDA-2022-N-1349]
FR document: [FR Doc. 2022-14798 Filed 7-11-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1349]
Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of August 11, 2022.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in §?314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under §?314.150(c) is without prejudice to refiling.
Application No. | Drug | Applicant |
---|---|---|
ANDA 040846 | Hydrocodone Bitartrate and Acetaminophen Tablets, 325 milligrams (mg); 2.5 mg | Mikart, LLC, 1750 Chattahoochee Ave. NW, Atlanta, GA 30318. |
ANDA 040851 | Benzonatate Capsules, 100 mg, 150 mg, and 200 mg | Do. |
ANDA 072903 | Ibuprofen Tablets, 200 mg | ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623. |
ANDA 073519 | Tolmetin Sodium Capsules, Equivalent to (EQ) 400 mg base | Do. |
ANDA 074267 | Guanabenz Acetate Tablets, EQ 4 mg base and EQ 8 mg base | Do. |
ANDA 074498 | Indapamide Tablets, 1.25 mg and 2.5 mg | Do. |
ANDA 074840 | Etodolac Capsules, 200 mg and 300 mg | Do. |
ANDA 074844 | Etodolac Capsules, 200 mg and 300 mg | Do. |
ANDA 075212 | Ranitidine Hydrochloride (HCl) Tablets, EQ 75 mg base | Do. |
ANDA 076030 | Flecainide Acetate Tablets, 50 mg, 100 mg, and 150 mg | Do. |
ANDA 076086 | Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg | Do. |
ANDA 077426 | Ranitidine HCl Tablets, EQ 150 mg base and EQ 300 mg base | Do. |
ANDA 077641 | Zonisamide Capsules, 25 mg, 50 mg, and 100 mg | Do. |
ANDA 077979 | Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg, and 3 mg | Do. |
ANDA 085269 | Meclizine HCl Tablets, 12.5 mg | Do. |
ANDA 085740 | Meclizine HCI Tablets, 25 mg | Do. |
ANDA 087296 | Chlorthalidone Tablets, 25 mg | Do. |
ANDA 088164 | Chlorthalidone Tablets, 25 mg | Do. |
ANDA 088641 | Glucamide Tablets, 250 mg | Do. |
ANDA 088732 | Meclizine HCl Tablets, 12.5 mg | Do. |
ANDA 088768 | Chlorpropamide Tablets, 100 mg | Do. |
ANDA 088826 | Chlorpropamide Tablets, 250 mg | Do. |
ANDA 090572 | Cetirizine HCl, Syrup 5 mg/5 milliliters (mL) | Tris Pharma, Inc., 2031 U.S. Hwy. 130, Suite D, Monmouth Junction, NJ 08852. |
ANDA 090906 | Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1 gram (gm) | Alvogen PB Research and Development, U.S. Agency for Lotus Pharmaceutical Co., Ltd., Nantou Plant, 44 Whippany Rd., Suite 300, Morristown, NJ 07960. |
ANDA 201944 | Potassium Chloride Extended Release Capsules, 8 milliequivalent (mEq) and 10 mEq | Tris Pharma, Inc. |
ANDA 202095 | Levetiracetam Extended Release Tablets, 500 mg and 750 mg | Alvogen PB Research and Development, U.S. Agency for Lotus Pharmaceutical Co., Ltd. |
ANDA 202246 | Levonorgestrel Tablets, 1.5 mg | Alvogen, Inc., 44 Whippany Rd., Suite 300, Morristown, NJ 07960. |
ANDA 203298 | Calcium Acetate Capsules, 667 mg | Alvogen PB Research and Development, U.S. Agency for Lotus Pharmaceutical Co., Ltd. |
ANDA 204180 | Amiloride HCl Tablets, 5 mg | USpharma Windlas, LLC, 115 Blue Jay Dr., Suite 101, Liberty, MO 64068. |
ANDA 205442 | Linezolid Injection, 600 mg/300 mL (2 mg/mL) | Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. |
ANDA 205790 | Prasugrel Tablets, EQ 5 mg base and EQ 10 mg base | USpharma Windlas, LLC. |
[top] Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 11, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and
Dated: July 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14798 Filed 7-11-22; 8:45 am]
BILLING CODE 4164-01-P