← FDA DRUG APPROVALS

FDA NDA · NDA019737

METROGEL

Sponsor: GALDERMA LABS LP

APPLICATION
NDA019737
TYPE
NDA
ORIGINAL APPROVAL
1988-11-22
LATEST ACTION
2002-06-04
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

METROGEL · ReferenceDiscontinued
METRONIDAZOLE 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2002-06-04Manufacturing (CMC) · Supplement 7 · priority — Letter ↗AP
1995-08-21Labeling · Supplement 6 · standardAP
1994-03-24Manufacturing (CMC) · Supplement 5 · priorityAP
1990-05-15Manufacturing (CMC) · Supplement 4 · priorityAP
1989-06-20Manufacturing (CMC) · Supplement 3 · priorityAP
1989-01-19Manufacturing (CMC) · Supplement 2 · priorityAP
1988-12-02Manufacturing (CMC) · Supplement 1 · priorityAP
1988-11-22Type 3 - New Dosage Form · Original · priorityAP
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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