← FDA DRUG APPROVALS

FDA NDA · NDA007513

LEVOPHED

norepinephrine bitartrate

Sponsor: HOSPIRA

APPLICATION
NDA007513
TYPE
NDA
ORIGINAL APPROVAL
1950-07-13
LATEST ACTION
2020-10-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LEVOPHED · ReferencePrescription
NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML · INJECTABLE · INJECTION

Approval history

2020-10-21Labeling · Supplement 45 · standard — Letter ↗AP
2020-06-15Labeling · Supplement 38 · standard — Letter ↗AP
2007-09-26Manufacturing (CMC) · Supplement 24 — Letter ↗AP
1999-09-20Labeling · Supplement 22 · standardAP
1991-09-13Labeling · Supplement 21AP
1991-06-12Manufacturing (CMC) · Supplement 20 · priorityAP
1989-04-06Labeling · Supplement 16AP
1988-03-02Labeling · Supplement 19AP
1987-05-27Labeling · Supplement 18AP
1985-01-14Labeling · Supplement 17AP
1978-04-14Manufacturing (CMC) · Supplement 15 · priorityAP
1977-02-14REMS · Supplement 9 · priorityAP
1950-07-13Type 1 - New Molecular Entity · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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