← FDA DRUG APPROVALS

FDA NDA · NDA021806

VANDAZOLE

metronidazole

Sponsor: TEVA PHARMS

APPLICATION
NDA021806
TYPE
NDA
ORIGINAL APPROVAL
2005-05-20
LATEST ACTION
2021-02-11
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

VANDAZOLEPrescription
METRONIDAZOLE 0.75% · GEL · VAGINAL

Approval history

2021-02-11Labeling · Supplement 8 · standard — Letter ↗AP
2014-01-29Manufacturing (CMC) · Supplement 4 · standardAP
2011-02-03Labeling · Supplement 3 · unknown — Label ↗AP
2006-09-07Manufacturing (CMC) · Supplement 1AP
2005-05-20Type 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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