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FDA NDA · NDA209463

PANTOPRAZOLE SODIUM

Sponsor: HIKMA

APPLICATION
NDA209463
TYPE
NDA
ORIGINAL APPROVAL
2017-06-30
LATEST ACTION
2023-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

PANTOPRAZOLE SODIUM · ReferencePrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2023-07-18Labeling · Supplement 21 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 15 · standard — Letter ↗AP
2021-07-26Manufacturing (CMC) · Supplement 13 — Letter ↗TA
2020-11-27Labeling · Supplement 11 · standard — Label ↗AP
2020-06-23Labeling · Supplement 6 · standard — Label ↗AP
2018-10-10Labeling · Supplement 5 · standard — Label ↗AP
2017-06-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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