APPLICATION
ANDA211359
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-18
LATEST ACTION
2020-08-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NOREPINEPHRINE BITARTRATEPrescription
NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2020-08-12Labeling · Supplement 1 · standardAP
2018-10-18UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.