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FDA NDA · NDA012623

FLAGYL

Sponsor: PFIZER

APPLICATION
NDA012623
TYPE
NDA
ORIGINAL APPROVAL
1963-07-18
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLAGYL · ReferenceDiscontinued
METRONIDAZOLE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FLAGYL · ReferenceDiscontinued
METRONIDAZOLE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-07-08Labeling · Supplement 72 · standard — Letter ↗AP
2023-10-06Labeling · Supplement 70 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 69 · standard — Label ↗AP
2021-03-05Labeling · Supplement 68 · standard — Letter ↗AP
2018-04-03Labeling · Supplement 67 · standard — Label ↗AP
2015-07-13Labeling · Supplement 66 · standard — Letter ↗AP
2013-08-16Labeling · Supplement 65 · standard — Label ↗AP
2010-08-19Labeling · Supplement 61 · unknown — Letter ↗AP
2004-03-17Labeling · Supplement 59 · standard — Letter ↗AP
2003-04-23Labeling · Supplement 58 · standard — Label ↗AP
1996-05-07Labeling · Supplement 49AP
1996-05-07Labeling · Supplement 53AP
1996-05-07Labeling · Supplement 51AP
1996-05-07Labeling · Supplement 48AP
1994-02-16Manufacturing (CMC) · Supplement 56 · priorityAP
1992-06-23Manufacturing (CMC) · Supplement 54 · priorityAP
1990-07-30Manufacturing (CMC) · Supplement 52 · priorityAP
1989-04-13Labeling · Supplement 50AP
1989-02-03Labeling · Supplement 47AP
1988-02-10Efficacy · Supplement 41AP
1987-12-28Labeling · Supplement 45AP
1987-11-03Labeling · Supplement 40AP
1987-08-21Labeling · Supplement 38AP
1987-06-18Manufacturing (CMC) · Supplement 46 · priorityAP
1986-07-22Labeling · Supplement 44AP
1984-03-30Labeling · Supplement 37AP
1983-10-18Labeling · Supplement 35AP
1983-10-18Labeling · Supplement 34AP
1983-06-02Manufacturing (CMC) · Supplement 36 · priorityAP
1982-05-05Manufacturing (CMC) · Supplement 33 · priorityAP
1982-02-04Manufacturing (CMC) · Supplement 31 · priorityAP
1981-08-13Manufacturing (CMC) · Supplement 32 · priorityAP
1981-08-04Manufacturing (CMC) · Supplement 30 · priorityAP
1980-12-12Manufacturing (CMC) · Supplement 29 · priorityAP
1980-12-08Labeling · Supplement 27AP
1980-02-27Manufacturing (CMC) · Supplement 26 · priorityAP
1980-01-09Manufacturing (CMC) · Supplement 28 · priorityAP
1980-01-02Manufacturing (CMC) · Supplement 25 · priorityAP
1979-07-26Labeling · Supplement 24AP
1979-04-19Manufacturing (CMC) · Supplement 22 · priorityAP
VIEW ON DRUGS@FDA ↗

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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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