Imiquimod

Treats clinically typical, visible, or palpable actinic keratoses (AK) of the face or…. ANDA 205971, held by Taro. Imiquimod.

As of Nov 14, 2026, ANDA 205971 (Imiquimod), held by Taro, was first approved by FDA on Jan 26, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 26, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults.

Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. 1.1 Actinic Keratosis

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 26, 2021	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imiquimod3.75% · cream;topical	Imiquimod	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 3, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jan 26, 2021	Original application	Approved	Letter

Identifiers

Application: ANDA 205971
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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