For severe. ANDA 219443, held by Biocon Pharma. Norepinephrine Bitartrate.
As of Nov 15, 2026, ANDA 219443 (Norepinephrine Bitartrate), held by Biocon Pharma, was first approved by FDA on Mar 21, 2025, 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 |
|---|---|---|---|
| Mar 21, 2025 | 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
