Skip to contentApplication 090384
- Type
- ANDA
- Sponsor
- APP PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PEMETREXED | PEMETREXED | INJECTABLE; INJECTION | 500MG | No | No |
| 002 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 100MG | No | No |
| 003 | PEMETREXED | PEMETREXED | INJECTABLE;INJECTION | 1G | No | No |
| 004 | PEMETREXED DISODIUM | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-134 | Pemetrexed | PEMETREXED DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-450 | Pemetrexed | PEMETREXED DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-621 | Pemetrexed | PEMETREXED DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-622 | Pemetrexed | PEMETREXED DISODIUM | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71899 | ORIG | 2022-08-26 |