For severe. ANDA 214323, held by Gland. Norepinephrine Bitartrate.
As of Nov 15, 2026, ANDA 214323 (Norepinephrine Bitartrate), held by Gland, was first approved by FDA on May 6, 2021, 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 |
|---|---|---|---|
| May 6, 2021 | 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
