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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202376

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NDA 202376 describes RABEPRAZOLE SODIUM, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Kremers Urban Pharms, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nine NDAs. It is available from nineteen suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are twenty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for 202376

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202376

Mechanism of ActionProton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for 202376

Suppliers and Packaging for NDA: 202376

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 202376 ANDA Major Pharmaceuticals 0904-6375 0904-6375-61 100 TABLET, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0904-6375-61)
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 202376 ANDA Torrent Pharmaceuticals Limited 13668-107 13668-107-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Nov 8, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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