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Treats clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on…. ANDA 78837, held by Padagis Israel. Imiquimod.
As of Nov 14, 2026, ANDA 78837 (Imiquimod), held by Padagis Israel, was first approved by FDA on Sep 7, 2010, with 2 approved supplements and 0 published complete response letters.
First approved: Sep 7, 2010
Supplements approved: 2
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
