Application 019915
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | MONOPRIL | FOSINOPRIL SODIUM | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MONOPRIL | FOSINOPRIL SODIUM | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | MONOPRIL | FOSINOPRIL SODIUM | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 1811 | SUPPL | 2009-02-13 |
| 23561 | ORIG | 2006-06-09 |
| 19843 | SUPPL | 2003-11-05 |
| 41094 | SUPPL | 2003-07-08 |
| 34099 | SUPPL | 2003-06-08 |
| 1810 | SUPPL | 2003-06-08 |
| 19842 | SUPPL | 2002-08-29 |
| 51963 | SUPPL | 1900-01-01 |
| 51962 | SUPPL | 1900-01-01 |
| 51961 | SUPPL | 1900-01-01 |
| 51960 | SUPPL | 1900-01-01 |