Application 021007
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AGENERASE | AMPRENAVIR | CAPSULE;ORAL | 50MG | No | No |
| 002 | AGENERASE | AMPRENAVIR | CAPSULE;ORAL | 150MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 4026 | SUPPL | 2005-11-18 |
| 35869 | SUPPL | 2005-11-16 |
| 41871 | ORIG | 2004-05-26 |
| 21351 | SUPPL | 2004-05-26 |
| 14152 | SUPPL | 2004-04-05 |
| 4025 | SUPPL | 2004-03-02 |
| 35868 | SUPPL | 2002-10-02 |
| 26467 | SUPPL | 2002-10-02 |
| 14151 | SUPPL | 2002-10-02 |
| 4024 | SUPPL | 2002-10-02 |
| 26465 | SUPPL | 2002-08-02 |
| 14150 | SUPPL | 2002-08-02 |
| 26466 | SUPPL | 2002-02-05 |
| 26464 | SUPPL | 2002-02-05 |
| 14149 | SUPPL | 2001-05-11 |
| 4023 | SUPPL | 2001-05-11 |
| 35867 | ORIG | 1999-04-15 |
| 4022 | ORIG | 1999-04-15 |