Application 019901
- Type
- NDA
- Sponsor
- KING PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALTACE | RAMIPRIL | CAPSULE;ORAL | 1.25MG | Yes | No |
| 002 | ALTACE | RAMIPRIL | CAPSULE;ORAL | 2.5MG | Yes | No |
| 003 | ALTACE | RAMIPRIL | CAPSULE;ORAL | 5MG | Yes | No |
| 004 | ALTACE | RAMIPRIL | CAPSULE;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61570-110 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-110 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-110 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-110 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-111 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-111 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-111 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-111 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-112 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-112 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-112 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-112 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-120 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-120 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-120 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-120 | ALTACE | ramipril | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85925 | SUPPL | 2026-05-18 |
| 85863 | SUPPL | 2026-05-11 |
| 48204 | SUPPL | 2017-05-02 |
| 48127 | SUPPL | 2017-04-27 |
| 34086 | SUPPL | 2015-09-14 |
| 19824 | SUPPL | 2015-09-14 |
| 34085 | SUPPL | 2014-05-06 |
| 1796 | SUPPL | 2014-05-06 |
| 1795 | SUPPL | 2013-11-06 |
| 34084 | SUPPL | 2013-11-04 |
| 11833 | SUPPL | 2013-10-31 |
| 19823 | SUPPL | 2013-10-28 |
| 19822 | SUPPL | 2013-09-24 |
| 34083 | SUPPL | 2013-09-23 |
| 11832 | SUPPL | 2012-04-20 |
| 1794 | SUPPL | 2012-04-16 |
| 11831 | SUPPL | 2011-09-02 |
| 19821 | SUPPL | 2011-08-26 |
| 20418 | SUPPL | 2011-02-15 |
| 19820 | SUPPL | 2010-10-25 |
| 11830 | SUPPL | 2010-10-25 |
| 19818 | SUPPL | 2009-03-06 |
| 19819 | SUPPL | 2009-02-18 |
| 44039 | ORIG | 2006-06-09 |
| 20417 | SUPPL | 2005-04-15 |
| 19817 | SUPPL | 2004-11-16 |
| 1793 | SUPPL | 2004-10-22 |
| 1792 | SUPPL | 2004-10-22 |
| 1791 | SUPPL | 2004-10-22 |
| 1790 | SUPPL | 2002-08-02 |
| 19816 | SUPPL | 2002-07-10 |
| 20416 | SUPPL | 1998-12-16 |