Imiquimod

ANDA 91308, held by Apotex Inc. Imiquimod.

As of Nov 14, 2026, ANDA 91308 (Imiquimod), held by Apotex Inc, was first approved by FDA on Apr 6, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 6, 2012
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 6, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imiquimod5% · cream;topical	Imiquimod	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 24, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Apr 6, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91308
Drugs@FDA: Overview at FDA
Company: Apotex

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