Application 076875
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 1MG | No | No |
| 002 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 2MG | No | No |
| 003 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 4MG | No | No |
| 004 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 8MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8975 | ORIG | 2005-10-11 |