ANDA 40462, held by Hikma. Norepinephrine Bitartrate.
As of Nov 14, 2026, ANDA 40462 (Norepinephrine Bitartrate), held by Hikma, was first approved by FDA on Oct 31, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norepinephrine BitartrateEQ 1MG BASE/ML ยท 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
