← FDA DRUG APPROVALS

FDA NDA · NDA020743

METRONIDAZOLE

Sponsor: BAUSCH

APPLICATION
NDA020743
TYPE
NDA
ORIGINAL APPROVAL
1997-09-26
LATEST ACTION
2014-12-05
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

NORITATE · ReferencePrescription
METRONIDAZOLE 1% · CREAM · TOPICAL

Approval history

2014-12-05Manufacturing (CMC) · Supplement 12 · standardAP
2004-07-04Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2003-04-04Labeling · Supplement 2 · standard — Label ↗AP
1997-09-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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