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Generated: October 21, 2018

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Details for New Drug Application (NDA): 076822

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NDA 076822 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Lannett Co Inc, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in ten NDAs. It is available from twenty-three suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty 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 076822
Tradename:RABEPRAZOLE SODIUM
Applicant:Teva Pharms Usa
Ingredient:rabeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076822
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 076822
Suppliers and Packaging for NDA: 076822
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076822 ANDA Teva Pharmaceuticals USA, Inc. 0093-0064 0093-0064-56 30 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-0064-56)
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 076822 ANDA AvKARE, Inc. 42291-721 42291-721-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-721-30)

Profile for product number 001

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

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