Application 202700
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MODAFINIL | MODAFINIL | TABLET;ORAL | 100MG | No | No |
| 002 | MODAFINIL | MODAFINIL | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-105 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-106 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-385 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-386 | Modafinil | Modafinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 71335-1096 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1096 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1096 | Modafinil | Modafinil | Bryant Ranch Prepack | ANDA | Current |