Avc

NDA 6530, held by Pharmobedient. Sulfanilamide.

As of Nov 13, 2026, NDA 6530 (Avc), held by Pharmobedient, was first approved by FDA on Jun 5, 1965, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1965
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 5, 1965	Original application	Approved	None posted

Products

2 strengths and forms


Avc15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;vaginal	Sulfanilamide	DiscontinuedReference drug
Avc1.05GM · suppository;vaginal	Sulfanilamide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Apr 24, 2015	Supplement 20Manufacturing	Approved	None posted
Jan 18, 2013	Supplement 19Manufacturing	Approved	Label
Apr 19, 2002	Supplement 11Manufacturing	Approved	None posted
Jul 13, 2000	Supplement 10Manufacturing	Approved	None posted
Sep 24, 1992	Supplement 9Manufacturing	Approved	None posted
Jan 27, 1987	Supplement 4Manufacturing	Approved	None posted
Jan 27, 1987	Supplement 7Manufacturing	Approved	None posted
Jan 27, 1987	Supplement 8Labeling	Approved	None posted
Jun 5, 1965	Original application	Approved	None posted

Identifiers

Application: NDA 6530
Drugs@FDA: Overview at FDA
Company: PharmoBedient

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Avc