Treats hypertension. ANDA 90873, held by Actavis Labs Ut Inc. Clonidine.
As of Nov 14, 2026, ANDA 90873 (Clonidine), held by Actavis Labs Ut Inc, was first approved by FDA on May 6, 2014, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 2014 | Original application | Approved | None posted |
| Jun 17, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 6, 2014 | Original application | Approved | None posted |
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
