Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratosis (AK) on…. ANDA 201994, held by Glenmark Pharms. Imiquimod.
As of Nov 14, 2026, ANDA 201994 (Imiquimod), held by Glenmark Pharms, was first approved by FDA on Mar 6, 2012, with 1 approved supplement and 0 published complete response letters.
First approved: Mar 6, 2012
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Imiquimod cream is indicated for the topical treatment of:
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults.
Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
External genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older. 1.
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
