2024-31360. Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications  

  • Table 1—Approved ANDAs for Which Required Reports Have Not Been Submitted

    Application No. Drug Applicant
    ANDA 207309 Metronidazole tablet, 250 milligrams (mg) and 500 mg Flamingo Pharmaceuticals Ltd., U.S. Agent for Flamingo Pharmaceuticals Ltd., 1125 Gaither Rd., Rockville, MD 20850.
    ANDA 207938 Piroxicam capsule, 10 mg and 20 mg Do.

Document Information

Published:
12/31/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2024-31360
Dates:
Approval is withdrawn as of December 31, 2024.
Pages:
107146-107147 (2 pages)
Docket Numbers:
Docket No. FDA-2024-N-3271
PDF File:
2024-31360.pdf