NDA 208746, held by Hospira. Pemetrexed Ditromethamine.
As of Nov 13, 2026, NDA 208746 (Pemetrexed Ditromethamine), held by Hospira, was first approved by FDA on Jun 10, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Pemetrexed DitromethamineEQ 100MG BASE/VIAL · powder;intravenous | Pemetrexed Ditromethamine | DiscontinuedReference drug |
| Pemetrexed DitromethamineEQ 500MG BASE/VIAL · powder;intravenous | Pemetrexed Ditromethamine | DiscontinuedReference drug |
| Pemetrexed DitromethamineEQ 1GM BASE/VIAL · powder;intravenous | Pemetrexed Ditromethamine | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters