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FDA NDA · NDA020334

FLAGYL

metronidazole

Sponsor: PFIZER

APPLICATION
NDA020334
TYPE
NDA
ORIGINAL APPROVAL
1995-05-03
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FLAGYL · ReferencePrescription
METRONIDAZOLE 375MG · CAPSULE · ORAL

Approval history

2024-07-08Labeling · Supplement 15 · standard — Letter ↗AP
2023-10-06Labeling · Supplement 13 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 12 · standard — Label ↗AP
2021-03-05Labeling · Supplement 11 · standard — Letter ↗AP
2018-04-03Labeling · Supplement 10 · standard — Label ↗AP
2015-07-13Labeling · Supplement 9 · standard — Letter ↗AP
2013-08-16Labeling · Supplement 8 · unknown — Letter ↗AP
2010-08-19Labeling · Supplement 4 · unknown — Letter ↗AP
2004-03-17Labeling · Supplement 3 · standard — Label ↗AP
2003-04-23Labeling · Supplement 1 · standard — Letter ↗AP
1995-05-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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