ANDA 75994, held by Chartwell Rx. Lisinopril.
As of Nov 14, 2026, ANDA 75994 (Lisinopril), held by Chartwell Rx, was first approved by FDA on Jul 1, 2002, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2002 | Original application | Approved |
| Lisinopril2.5MG · tablet;oral | Lisinopril | Rx |
| Lisinopril5MG · tablet;oral | Lisinopril | Rx |
| Lisinopril10MG · tablet;oral | Lisinopril | Rx |
| Lisinopril20MG · tablet;oral | Lisinopril | Rx |
| Lisinopril30MG · tablet;oral | Lisinopril | Rx |
| Lisinopril40MG · tablet;oral | Lisinopril | Rx |
| Jan 11, 2019 | Supplement 56Labeling · Standard review | Approved | None posted |
| Jan 11, 2019 | Supplement 53Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 44Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 43Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 39Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 38Labeling · Standard review | Approved | None posted |
| Aug 14, 2013 | Supplement 35Labeling · Standard review | Approved | None posted |
| Feb 19, 2013 | Supplement 31Labeling · Standard review | Approved | None posted |
| Feb 19, 2013 | Supplement 29Labeling | Approved | None posted |
| Feb 19, 2013 | Supplement 27Labeling | Approved | None posted |
| Feb 29, 2008 | Supplement 24Labeling | Approved | None posted |
| Aug 14, 2007 | Supplement 19Labeling | Approved | None posted |
| Aug 30, 2005 | Supplement 10Labeling | Approved | None posted |
| Jun 16, 2005 | Supplement 7Labeling | 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
