Application 213251
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METOLAZONE | METOLAZONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | METOLAZONE | METOLAZONE | TABLET;ORAL | 5MG | No | No |
| 003 | METOLAZONE | METOLAZONE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7138 | METOLAZONE | METOLAZONE | Major Pharmaceuticals | ANDA | Current |
| 0904-7139 | METOLAZONE | METOLAZONE | Major Pharmaceuticals | ANDA | Current |
| 0904-7139 | METOLAZONE | METOLAZONE | Major Pharmaceuticals | ANDA | Current |
| 46708-532 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-533 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-534 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-532 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-532 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-532 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-532 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-533 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-533 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-533 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-533 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-534 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-534 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-534 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-534 | METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | ANDA | Current |