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FDA NDA · NDA204957

ACETAMINOPHEN

Sponsor: B BRAUN MEDICAL

APPLICATION
NDA204957
TYPE
NDA
ORIGINAL APPROVAL
2021-02-18
LATEST ACTION
2021-02-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ACETAMINOPHEN · ReferencePrescription
ACETAMINOPHEN 1GM/100ML (10MG/ML) · SOLUTION · INTRAVENOUS
ACETAMINOPHEN · ReferencePrescription
ACETAMINOPHEN 500MG/50ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-02-18Type 5 - New Formulation or New Manufacturer · 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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