Application 203359
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-099 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-099 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-099 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-099 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-099 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-100 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-100 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-100 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-100 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-100 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-101 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-101 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-101 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-101 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-101 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-103 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-103 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-103 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-103 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-103 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-104 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-104 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-104 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-104 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-104 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-105 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-105 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-105 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-105 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-105 | Quetiapine fumarate | Quetiapine fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 68788-7195 | Quetiapine fumarate | Quetiapine fumarate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7195 | Quetiapine fumarate | Quetiapine fumarate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1909 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1909 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1909 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2547 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2547 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2547 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2547 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2672 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2672 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2672 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2672 | Quetiapine fumarate | Quetiapine fumarate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1362 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1362 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1362 | Quetiapine fumarate | Quetiapine fumarate | Bryant Ranch Prepack | ANDA | Current |