Treats mild to moderate atopic dermatitis in non-immunocompromised adults and children 2…. ANDA 211769, held by Glenmark Pharms Ltd. Pimecrolimus.
As of Nov 14, 2026, ANDA 211769 (Pimecrolimus), held by Glenmark Pharms Ltd, was first approved by FDA on Aug 29, 2019, 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 cream, 1% is not indicated for use in children less than 2 years of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2019 | Original application | Approved | None posted |
| 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
