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FDA NDA · NDA021789

METRONIDAZOLE

Sponsor: GALDERMA LABS LP

APPLICATION
NDA021789
TYPE
NDA
ORIGINAL APPROVAL
2005-06-30
LATEST ACTION
2023-11-22
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

METROGEL · ReferencePrescription
METRONIDAZOLE 1% · GEL · TOPICAL

Approval history

2023-11-22Labeling · Supplement 13 · standard — Letter ↗AP
2022-03-16Labeling · Supplement 10 · standard — Label ↗AP
2022-03-16Labeling · Supplement 9 · standard — Label ↗AP
2015-01-12Manufacturing (CMC) · Supplement 6 · standardAP
2014-09-04Manufacturing (CMC) · Supplement 5 · standardAP
2011-10-19Labeling · Supplement 4 · unknown — Review ↗AP
2010-03-05Labeling · Supplement 3 · standard — Label ↗AP
2006-08-29Manufacturing (CMC) · Supplement 2AP
2005-11-14Labeling · Supplement 1 · standard — Letter ↗AP
2005-06-30Type 3 - New Dosage Form · Original · standard — Label ↗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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