Application 215479
- Type
- ANDA
- Sponsor
- HONG KONG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No |
| 002 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No |
| 003 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | No | No |
| 004 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71288-145 | Pemetrexed | Pemetrexed disodium | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-146 | Pemetrexed | Pemetrexed disodium | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-147 | Pemetrexed | Pemetrexed disodium | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-148 | Pemetrexed | Pemetrexed disodium | Meitheal Pharmaceuticals Inc. | ANDA | Current |