Application 214408
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 100MG/4ML (25MG/ML), | No | No |
| 002 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 500MG/20ML (25MG/ML) | No | No |
| 003 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 850MG/34ML (25MG/ML) | No | No |
| 004 | PEMETREXED | PEMETREXED | SOLUTION;INTRAVENOUS | 1000MG/40ML (25MG/ML). | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-522 | Pemetrexed | Pemetrexed disodium | Accord Healthcare Inc. | NDA | Current |
| 16729-522 | Pemetrexed | Pemetrexed disodium | Accord Healthcare Inc. | NDA | Current |
| 68001-550 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-551 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-552 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
| 68001-553 | Pemetrexed | Pemetrexed disodium | BluePoint Laboratories | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 80869 | SUPPL | 2025-01-17 |
| 75777 | SUPPL | 2023-10-16 |
| 75735 | SUPPL | 2023-10-16 |
| 74348 | ORIG | 2023-05-23 |
| 71615 | ORIG | 2022-07-21 |
| 71093 | ORIG | 2022-05-18 |