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Details for New Drug Application (NDA): 090678

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NDA 090678 describes RABEPRAZOLE SODIUM, which is a drug marketed by Teva Pharms Usa, Dr Reddys Labs Ltd, Breckenridge Pharm, Lupin Ltd, Torrent Pharms Ltd, Kremers Urban Dev, Amneal Pharms, and Mylan Pharms Inc, and is included in eight NDAs. It is available from fifteen 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-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for NDA: 090678

Tradename:
RABEPRAZOLE SODIUM
Applicant:
Kremers Urban Dev
Ingredient:
rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090678

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 090678

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 090678 ANDA AvKARE, Inc. 42291-722 42291-722-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-722-10)
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 090678 ANDA Unit Dose Services 50436-0302 50436-0302-1 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-0302-1)

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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