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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 Teva Pharms Usa, Dr Reddys Labs Ltd, Breckenridge Pharm, Lupin Ltd, Torrent Pharms Ltd, Kremers Urban Pharms, Amneal Pharms, and Mylan Pharms Inc, and is included in eight NDAs. It is available from sixteen 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: 076822

Teva Pharms Usa
rabeprazole sodium
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076822

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 076822

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET, DELAYED RELEASE;ORAL 076822 ANDA AvKARE, Inc. 42291-721 42291-721-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-721-30)

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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