Application 021039
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AGENERASE | AMPRENAVIR | SOLUTION;ORAL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 26567 | SUPPL | 2005-11-18 |
| 35960 | SUPPL | 2005-11-08 |
| 21370 | SUPPL | 2004-05-26 |
| 21369 | ORIG | 2004-05-26 |
| 14231 | SUPPL | 2004-04-05 |
| 4137 | SUPPL | 2004-03-02 |
| 35959 | SUPPL | 2002-10-02 |
| 26566 | SUPPL | 2002-10-02 |
| 14230 | SUPPL | 2002-10-02 |
| 4136 | SUPPL | 2002-10-02 |
| 26565 | SUPPL | 2002-08-02 |
| 14229 | SUPPL | 2002-08-02 |
| 26564 | SUPPL | 2002-02-05 |
| 4135 | SUPPL | 2002-02-05 |
| 26563 | SUPPL | 2001-05-11 |
| 14228 | SUPPL | 2001-05-11 |
| 14227 | ORIG | 1999-04-15 |
| 4134 | ORIG | 1999-04-15 |