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FDA NDA · NDA020901

METRONIDAZOLE

Sponsor: GALDERMA LABS LP

APPLICATION
NDA020901
TYPE
NDA
ORIGINAL APPROVAL
1998-11-24
LATEST ACTION
2015-01-07
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

METROLOTION · ReferencePrescription
METRONIDAZOLE 0.75% · LOTION · TOPICAL

Approval history

2015-01-07Labeling · Supplement 3 · standardAP
2004-05-11Labeling · Supplement 2 · standard — Label ↗AP
2002-12-06Manufacturing (CMC) · Supplement 1 · standardAP
1998-11-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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