Treats mild to moderate atopic dermatitis in non-immunocompromised adults and children 2…. ANDA 209345, held by Actavis Labs Ut Inc. Pimecrolimus.
As of Nov 14, 2026, ANDA 209345 (Pimecrolimus), held by Actavis Labs Ut Inc, was first approved by FDA on Dec 27, 2018, with 0 approved supplements and 0 published complete response letters.
Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus c ream, 1% is not indicated for use in children less than 2 years of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pimecrolimus1% · cream;topical | Pimecrolimus | Rx |
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
