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FDA NDA · NDA205223

NUVESSA

metronidazole

Sponsor: ALEMBIC THERAP

APPLICATION
NDA205223
TYPE
NDA
ORIGINAL APPROVAL
2014-03-24
LATEST ACTION
2022-02-25
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

NUVESSA · ReferencePrescription
METRONIDAZOLE 1.3% · GEL · VAGINAL

Approval history

2022-02-25Labeling · Supplement 6 · standard — Letter ↗AP
2021-12-06Labeling · Supplement 5 · standard — Letter ↗AP
2018-08-03Efficacy · Supplement 2 · priority — Label ↗AP
2014-12-14Labeling · Supplement 1 · standardAP
2014-03-24Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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