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FDA NDA · NDA219935

FAMOTIDINE

Sponsor: SAGENT

APPLICATION
NDA219935
TYPE
NDA
ORIGINAL APPROVAL
2025-07-16
LATEST ACTION
2025-07-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FAMOTIDINE · ReferencePrescription
FAMOTIDINE 20MG/5ML (4MG/ML) · SOLUTION · INTRAVENOUS
FAMOTIDINE · ReferencePrescription
FAMOTIDINE 40MG/10ML (4MG/ML) · SOLUTION · INTRAVENOUS
FAMOTIDINE · ReferencePrescription
FAMOTIDINE 200MG/50ML (4MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-07-16Type 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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