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FDA NDA · NDA215425

EPINEPHRINE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA215425
TYPE
NDA
ORIGINAL APPROVAL
2025-03-13
LATEST ACTION
2025-03-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EPINEPHRINE · ReferencePrescription
EPINEPHRINE 30MG/30ML (1MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2025-03-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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