Application 214657
- Type
- NDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | Pemetrexed | Pemetrexed | SOLUTION;INTRAVENOUS | 100MG/4ML (25 mg/mL) | No | No |
| 002 | Pemetrexed | Pemetrexed | SOLUTION; INJECTION | 500MG/20ML (25MG/ML) | No | No |
| 003 | PEMETREXED | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3518 | Pemetrexed | Pemetrexed disodium | Sandoz Inc. | NDA | Current |
| 0781-3518 | Pemetrexed | Pemetrexed disodium | Sandoz Inc. | NDA | Current |
| 0781-3519 | Pemetrexed | Pemetrexed disodium | Sandoz Inc. | NDA | Current |
| 0781-3519 | Pemetrexed | Pemetrexed disodium | Sandoz Inc. | NDA | Current |
| 0781-3520 | Pemetrexed | Pemetrexed disodium | Sandoz Inc. | NDA | Current |