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FDA NDA · NDA006530

AVC

Sponsor: PHARMOBEDIENT

APPLICATION
NDA006530
TYPE
NDA
ORIGINAL APPROVAL
1965-06-05
LATEST ACTION
2015-04-24
ROUTE
VAGINAL
DOSAGE FORM
CREAM, SUPPOSITORY
MARKETING STATUS
Discontinued

Products

AVC · ReferenceDiscontinued
SULFANILAMIDE 15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · VAGINAL
AVCDiscontinued
SULFANILAMIDE 1.05GM · SUPPOSITORY · VAGINAL

Approval history

2015-04-24Manufacturing (CMC) · Supplement 20AP
2013-01-18Manufacturing (CMC) · Supplement 19 — Label ↗AP
2002-04-19Manufacturing (CMC) · Supplement 11AP
2000-07-13Manufacturing (CMC) · Supplement 10AP
1992-09-24Manufacturing (CMC) · Supplement 9AP
1987-01-27Manufacturing (CMC) · Supplement 7AP
1987-01-27Labeling · Supplement 8AP
1987-01-27Manufacturing (CMC) · Supplement 4AP
1965-06-05UNKNOWN · Original · unknownAP
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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