ANDA 219692, held by Sagent. Norepinephrine Bitartrate.
As of Nov 15, 2026, ANDA 219692 (Norepinephrine Bitartrate In 5% Dextrose), held by Sagent, was first approved by FDA on Aug 11, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2025 | Original application | Approved | None posted |
| Norepinephrine Bitartrate In 5% DextroseEQ 4MG BASE/250ML (EQ 16MCG BASE/ML) · solution;intravenous | Norepinephrine Bitartrate | Rx |
| Norepinephrine Bitartrate In 5% DextroseEQ 8MG BASE/250ML (EQ 32MCG BASE/ML) · solution;intravenous | 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
