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Application 214218
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 100MG/4ML(25MG/ML) | Yes | No |
| 002 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 500MG/20ML(25MG/ML) | Yes | No |
| 003 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 1G/40ML(25MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-1045 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-1045 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-1045 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-2188 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-2188 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-2188 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-3532 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-3532 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
| 0409-3532 | PEMETREXED | PEMETREXED | Hospira, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73739 | ORIG | 2023-03-13 |
| 72873 | ORIG | 2022-12-13 |
| 66345 | ORIG | 2021-02-24 |