For severe. ANDA 211382, held by Fresenius Kabi USA. Norepinephrine Bitartrate.
As of Nov 14, 2026, ANDA 211382 (Norepinephrine Bitartrate), held by Fresenius Kabi USA, was first approved by FDA on Nov 3, 2020, with 0 approved supplements and 0 published complete response letters.
Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norepinephrine BitartrateEQ 1MG BASE/ML · injectable;injection | Norepinephrine Bitartrate | 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
