Application 020720
- Type
- NDA
- Sponsor
- PFIZER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REZULIN | TROGLITAZONE | TABLET;ORAL | 200MG | No | No |
| 002 | REZULIN | TROGLITAZONE | TABLET;ORAL | 400MG | No | No |
| 003 | REZULIN | TROGLITAZONE | TABLET;ORAL | 300MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41620 | SUPPL | 2003-06-17 |
| 41618 | SUPPL | 2003-06-17 |
| 41615 | SUPPL | 2003-06-17 |
| 20879 | SUPPL | 2003-06-17 |
| 41621 | SUPPL | 1999-06-16 |
| 35227 | SUPPL | 1999-06-16 |
| 25632 | SUPPL | 1999-06-16 |
| 25631 | SUPPL | 1999-06-16 |
| 20880 | SUPPL | 1999-06-16 |
| 13286 | SUPPL | 1999-06-16 |
| 41619 | SUPPL | 1997-08-14 |
| 41617 | SUPPL | 1997-08-14 |
| 41616 | SUPPL | 1997-08-04 |