Application 213248
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 002 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
| 003 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 005 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-494 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-495 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-496 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-497 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-498 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-494 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-495 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-496 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-497 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-498 | Lurasidone Hydrochloride | Lurasidone Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |