For severe. NDA 7513, held by Hospira. Norepinephrine Bitartrate.
As of Nov 13, 2026, NDA 7513 (Levophed), held by Hospira, was first approved by FDA on Jul 13, 1950, with 12 approved supplements and 0 published complete response letters.
LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension. LEVOPHED is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 1950 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| LevophedEQ 1MG BASE/ML · injectable;injection | Norepinephrine Bitartrate | RxReference drug |
| Oct 21, 2020 | Supplement 45Labeling · Standard review | Approved | |
| Jun 15, 2020 | Supplement 38Labeling · Standard review | Approved | |
| Sep 26, 2007 | Supplement 24Manufacturing | Approved | |
| Sep 20, 1999 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 13, 1991 | Supplement 21Labeling | Approved | None posted |
| Jun 12, 1991 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1989 | Supplement 16Labeling | Approved | None posted |
| Mar 2, 1988 | Supplement 19Labeling | Approved | None posted |
| May 27, 1987 | Supplement 18Labeling | Approved | None posted |
| Jan 14, 1985 | Supplement 17Labeling | Approved | None posted |
| Apr 14, 1978 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1977 | Supplement 9REMS · Priority review | Approved | None posted |
| Jul 13, 1950 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
