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FDA NDA · NDA206030

CARNEXIV

Sponsor: LUNDBECK PHARMS LLC

APPLICATION
NDA206030
TYPE
NDA
ORIGINAL APPROVAL
2016-10-07
LATEST ACTION
2019-12-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CARNEXIV · ReferenceDiscontinued
CARBAMAZEPINE 200MG/20ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2019-12-12Labeling · Supplement 2 · standard — Letter ↗AP
2016-10-07Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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