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Last Updated: November 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090678

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NDA 090678 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Lannett Co Inc, Lupin Ltd, Mylan, Rubicon, Teva Pharms Usa, and Torrent, and is included in ten NDAs. It is available from twenty-two 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-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 090678
Applicant:Lannett Co Inc
Ingredient:rabeprazole sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 090678
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 090678
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 A-S Medication Solutions 50090-3145 50090-3145-0 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3145-0)

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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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