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FDA NDA · NDA020868

FLAGYL ER

Sponsor: PFIZER

APPLICATION
NDA020868
TYPE
NDA
ORIGINAL APPROVAL
1997-11-26
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

FLAGYL ER · ReferenceDiscontinued
METRONIDAZOLE 750MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-07-08Labeling · Supplement 17 · standard — Letter ↗AP
2023-10-06Labeling · Supplement 15 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 14 · standard — Label ↗AP
2021-03-05Labeling · Supplement 13 · standard — Letter ↗AP
2018-04-03Labeling · Supplement 12 · standard — Label ↗AP
2015-07-13Labeling · Supplement 11 · standard — Letter ↗AP
2015-04-14Manufacturing (CMC) · Supplement 10 · standardAP
2013-08-16Labeling · Supplement 9 · unknown — Letter ↗AP
2010-08-19Labeling · Supplement 8 · unknown — Label ↗AP
2004-03-17Labeling · Supplement 6 · standard — Letter ↗AP
2003-04-23Labeling · Supplement 5 · standard — Letter ↗AP
1998-11-04Manufacturing (CMC) · Supplement 4 · standardAP
1998-10-08Labeling · Supplement 3 · standardAP
1998-07-24Manufacturing (CMC) · Supplement 2 · standardAP
1998-02-20Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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