Application 208419
- Type
- NDA
- Sponsor
- ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 100MG/4ML | No | No |
| 002 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 500MG/20ML | No | No |
| 003 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 1G/40ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0480-4514 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4514 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4515 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4515 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4516 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
| 0480-4516 | Pemetrexed | Pemetrexed | Teva Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74566 | ORIG | 2023-06-21 |
| 72712 | SUPPL | 2022-11-25 |
| 72711 | SUPPL | 2022-11-25 |
| 72710 | SUPPL | 2022-11-25 |
| 72677 | SUPPL | 2022-11-23 |
| 72676 | SUPPL | 2022-11-23 |
| 72675 | SUPPL | 2022-11-23 |
| 68043 | ORIG | 2021-07-12 |
| 64400 | ORIG | 2020-08-24 |