ANDA 214436, held by Baxter Hlthcare Corp. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 214436 (Pemetrexed Disodium), held by Baxter Hlthcare Corp, was first approved by FDA on Aug 18, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2022 | Original application | Approved | None posted |
| Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Aug 29, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 18, 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
