Application 020550
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALTREX | VALACYCLOVIR HYDROCHLORIDE | Tablet; Oral | EQ 500MG BASE | No | No |
| 002 | VALTREX | VALACYCLOVIR HYDROCHLORIDE | TABLET; ORAL | EQ 1GM BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 25156 | SUPPL | 2004-06-29 |
| 20716 | SUPPL | 2004-06-14 |
| 25157 | SUPPL | 2003-09-09 |
| 34813 | SUPPL | 2003-08-29 |
| 25158 | SUPPL | 2003-08-15 |
| 12716 | SUPPL | 2003-04-25 |
| 12715 | SUPPL | 2003-04-25 |
| 12714 | SUPPL | 2003-04-25 |
| 2706 | SUPPL | 2003-04-18 |
| 12713 | SUPPL | 2003-04-01 |
| 2707 | SUPPL | 2002-09-09 |
| 20715 | SUPPL | 1997-09-26 |
| 52379 | ORIG | 1900-01-01 |
| 52378 | ORIG | 1900-01-01 |