Application 214073
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No |
| 002 | PEMETREXED | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No |
| 003 | PEMETREXED | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A214073-001 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
| A214073-002 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
| A214073-003 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS | AP | | 2022-05-25 |
Therapeutic equivalence codes#
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70710-1654 | pemetrexed | pemetrexed disodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1655 | pemetrexed | pemetrexed disodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1674 | pemetrexed | pemetrexed disodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1691 | pemetrexed | pemetrexed disodium | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1692 | pemetrexed | pemetrexed disodium | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1693 | pemetrexed | pemetrexed disodium | Zydus Lifesciences Limited | ANDA | Current |