Application 213223
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No |
| 002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No |
| 003 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-491 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-492 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-493 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-491 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-491 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-491 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-492 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-492 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-492 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-493 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-493 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-493 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Alembic Pharmaceuticals Inc. | ANDA | Current |