Treats hypertension. ANDA 78508, held by Epic Pharma. Trandolapril.
As of Nov 14, 2026, ANDA 78508 (Trandolapril), held by Epic Pharma, was first approved by FDA on Jun 18, 2008, with 5 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 18, 2008 | Original application | Approved | None posted |
| Trandolapril2MG · tablet;oral | Trandolapril | Rx |
| Trandolapril4MG · tablet;oral | Trandolapril | Rx |
| Trandolapril1MG · tablet;oral | Trandolapril | Rx |
| Feb 19, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 19, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 4, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 4, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 4, 2014 | Supplement 2Manufacturing | Approved | None posted |
| Jun 18, 2008 | 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
