Application 203485
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED | PEMETREXED DISODIUM | INJECTABLE;INJECTION | 100MG | No | No |
| 002 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No |
| 003 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-229 | Pemetrexed | Pemetrexed | Accord Healthcare Inc. | ANDA | Current |
| 16729-230 | Pemetrexed | Pemetrexed | Accord Healthcare Inc. | ANDA | Current |
| 16729-244 | Pemetrexed | Pemetrexed | Accord Healthcare Inc. | ANDA | Current |
| 68001-547 | Pemetrexed | Pemetrexed | BluePoint Laboratories | ANDA | Current |
| 68001-548 | Pemetrexed | Pemetrexed | BluePoint Laboratories | ANDA | Current |
| 68001-549 | Pemetrexed | Pemetrexed | BluePoint Laboratories | ANDA | Current |