Application 211574
- Type
- ANDA
- Sponsor
- ALEMBIC GLOBAL HOLDING SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 1MG/ML | No | No |
| 002 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 2.5MG/ML | No | No |
| 003 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 5MG/ML | No | No |
| 004 | TREPROSTINIL | TREPROSTINIL | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-514 | Treprostinil | Treprostinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-515 | Treprostinil | Treprostinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-516 | Treprostinil | Treprostinil | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-517 | Treprostinil | Treprostinil | Alembic Pharmaceuticals Inc. | ANDA | Current |