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FDA NDA · NDA217512

PANTOPRAZOLE SODIUM

pantoprazole sodium in 0.9% sodium chloride

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA217512
TYPE
NDA
ORIGINAL APPROVAL
2024-02-14
LATEST ACTION
2024-02-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) · SOLUTION · INTRAVENOUS
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) · SOLUTION · INTRAVENOUS
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-02-14Type 3 - New Dosage Form · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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