Treats hypertension. ANDA 79090, held by Dr Reddys Labs SA. Clonidine.
As of Nov 14, 2026, ANDA 79090 (Clonidine), held by Dr Reddys Labs SA, was first approved by FDA on Aug 20, 2010, 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 |
|---|---|---|---|
| Aug 20, 2010 | Original application | Approved | None posted |
| May 29, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 20, 2010 | 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
