NDA 22021, held by King Pfizer. Ramipril.
As of Nov 14, 2026, NDA 22021 (Altace), held by King Pfizer, was first approved by FDA on Feb 27, 2007, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Altace1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ramipril | DiscontinuedReference drug |
| Altace2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ramipril | DiscontinuedReference drug |
| Altace5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ramipril | DiscontinuedReference drug |
| Altace10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ramipril | DiscontinuedReference drug |
| Jan 18, 2012 | Supplement 8Labeling · Standard review | Approved | |
| Aug 4, 2011 | Supplement 7Labeling · Standard review | Approved | |
| Nov 20, 2009 | Supplement 6Labeling · Standard review | Approved | |
| Mar 4, 2009 | Supplement 1Labeling · Standard review | Approved | |
| Feb 9, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Feb 27, 2007 | Original applicationNew dosage form · Standard review | 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
