Treats hypertension. ANDA 212041, held by Sciegen Pharms. Lisinopril.
As of Nov 14, 2026, ANDA 212041 (Lisinopril), held by Sciegen Pharms, was first approved by FDA on Sep 15, 2020, with 0 approved supplements and 0 published complete response letters.
Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older Adjunct therapy for heart failure Treatment of Acute Myocardial Infarction
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2020 | Original application | Approved | None posted |
| Lisinopril2.5MG · tablet;oral | Lisinopril | Rx |
| Lisinopril5MG · tablet;oral | Lisinopril | Rx |
| Lisinopril10MG · tablet;oral | Lisinopril | 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
