ANDA 214073, held by Zydus Pharms. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 214073 (Pemetrexed Disodium), held by Zydus Pharms, was first approved by FDA on May 25, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 2022 | Original application | Approved | None posted |
| Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Rx |
| Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Rx |
| Pemetrexed DisodiumEQ 1GM BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Rx |
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