Application 203390
- Type
- ANDA
- Sponsor
- ALEMBIC 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 |
|---|
| 46708-134 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-134 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-135 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-135 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-136 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-136 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-137 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-137 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-138 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-138 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-139 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-139 | Quetiapine Fumarate | quetiapine fumarate | Alembic Pharmaceuticals Limited | ANDA | Current |