Treats hypertension. ANDA 77522, held by Lupin. Trandolapril.
As of Nov 14, 2026, ANDA 77522 (Trandolapril), held by Lupin, was first approved by FDA on Jun 12, 2007, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Trandolapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2007 | Original application | Approved | None posted |
| Trandolapril1MG · tablet;oral | Trandolapril | Rx |
| Trandolapril2MG · tablet;oral | Trandolapril | Rx |
| Trandolapril4MG · tablet;oral | Trandolapril | Rx |
| Aug 26, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 21, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 21, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 21, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jul 30, 2010 | Supplement 5Labeling | Approved | None posted |
| Oct 15, 2009 | Supplement 3Labeling | Approved | None posted |
| Jun 12, 2007 | 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
