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- Approval is withdrawn as of December 31, 2024.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