Application 020286
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MONOPRIL-HCT | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | MONOPRIL-HCT | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|
| 2294 | SUPPL | 2009-02-13 |
| 24732 | SUPPL | 2003-11-05 |