Application 078670
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 15MG BASE | No | No |
| 002 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | No | No |
| 003 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 45MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5420 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 0781-5420 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 0781-5421 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 0781-5421 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 0781-5422 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 0781-5422 | Pioglitazone | pioglitazone | Sandoz Inc | ANDA | Current |
| 70518-2324 | Pioglitazone | pioglitazone | REMEDYREPACK INC. | ANDA | Current |
| 71335-1659 | Pioglitazone | pioglitazone | Bryant Ranch Prepack | ANDA | Current |