Application 202467
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-645 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 16714-645 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 16714-646 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 16714-646 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 16714-647 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 16714-647 | Pioglitazone | Pioglitazone | NorthStar RxLLC | ANDA | Current |
| 33342-054 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-054 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-054 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-055 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-055 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-055 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-056 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-056 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-056 | Pioglitazone | Pioglitazone | Macleods Pharmaceuticals Limited | ANDA | Current |
| 50090-2637 | Pioglitazone | Pioglitazone | A-S Medication Solutions | ANDA | Current |
| 68071-2264 | Pioglitazone | Pioglitazone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2264 | Pioglitazone | Pioglitazone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-0088 | Pioglitazone | Pioglitazone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0088 | Pioglitazone | Pioglitazone | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10056 | ORIG | 2013-02-08 |