ANDA 76071, held by Strides Pharma. Lisinopril.
As of Nov 14, 2026, ANDA 76071 (Lisinopril), held by Strides Pharma, was first approved by FDA on Jul 1, 2002, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2002 | Original application | Approved |
| Lisinopril2.5MG · tablet;oral | Lisinopril | Discontinued |
| Lisinopril5MG · tablet;oral | Lisinopril | Discontinued |
| Lisinopril10MG · tablet;oral | Lisinopril | Discontinued |
| Lisinopril20MG · tablet;oral | Lisinopril | Discontinued |
| Lisinopril30MG · tablet;oral | Lisinopril | Discontinued |
| Lisinopril40MG · tablet;oral | Lisinopril | Discontinued |
| Apr 11, 2024 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 8, 2016 | Supplement 32Labeling · Standard review | Approved | None posted |
| Dec 26, 2015 | Supplement 31Labeling · Standard review | Approved | None posted |
| Jun 13, 2015 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jun 13, 2015 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 13, 2015 | Supplement 27Labeling · Standard review | Approved | None posted |
| Mar 1, 2013 | Supplement 20Labeling | Approved | None posted |
| Mar 1, 2013 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 1, 2013 | Supplement 23Labeling · Standard review | Approved | None posted |
| Mar 8, 2010 | Supplement 19Labeling | Approved | None posted |
| Oct 16, 2009 | Supplement 17Labeling | Approved | None posted |
| Feb 21, 2008 | Supplement 8Labeling | Approved | None posted |
| Jul 1, 2002 | Original application | Approved |
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
