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As of Nov 14, 2026, ANDA 200173 (Imiquimod), held by Taro, was first approved by FDA on Apr 15, 2011, with 2 approved supplements and 0 published complete response letters.
First approved: Apr 15, 2011
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Imiquimod Cream USP, 5% 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; maximum tumor diameter of 2.0 cm on trunk, 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/condyloma acuminata in patients 12 years old or older. Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 2-12 ( 1.4, 8.4 ) 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
