Application 018731
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUSPAR | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | BUSPAR | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | BUSPAR | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | BUSPAR | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|
| 57619 | ORIG | 2019-02-15 |
| 1055 | SUPPL | 2010-11-30 |
| 11309 | SUPPL | 2010-11-22 |
| 33583 | SUPPL | 2007-09-26 |
| 16016 | SUPPL | 2007-09-25 |
| 20153 | SUPPL | 2004-04-14 |
| 33582 | SUPPL | 2003-04-14 |
| 11307 | SUPPL | 2003-04-14 |
| 1054 | SUPPL | 2002-02-07 |
| 16015 | SUPPL | 2001-07-19 |
| 11308 | SUPPL | 2001-07-19 |