ANDA 210047, held by Amneal. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 210047 (Pemetrexed Disodium), held by Amneal, was first approved by FDA on Aug 4, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2022 | Original application | Approved | None posted |
| Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Jan 20, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 4, 2022 | Original application | Approved | None posted |
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
