ANDA 208927, held by Biocon Ltd. Pemetrexed.
As of Nov 14, 2026, ANDA 208927 (Pemetrexed), held by Biocon Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2018 | Original application | Tentative approval | None posted |
| Pemetrexed100MG · injectable;injection | Pemetrexed | None (tentative approval) |
| Pemetrexed500MG · injectable;injection | Pemetrexed | None (tentative approval) |
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