ANDA 216341, held by Zydus Pharms. Norepinephrine Bitartrate.
As of Nov 14, 2026, ANDA 216341 (Norepinephrine Bitartrate), held by Zydus Pharms, was first approved by FDA on Jul 19, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norepinephrine BitartrateEQ 1MG BASE/ML ยท injectable;injection | Norepinephrine Bitartrate | Discontinued |
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
