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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078964


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NDA 078964 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, 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-one 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-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 078964
Tradename:RABEPRAZOLE SODIUM
Applicant:Lupin Ltd
Ingredient:rabeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078964
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 078964
Suppliers and Packaging for NDA: 078964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 078964 ANDA medsource pharmaceuticals 45865-802 45865-802-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-30)
RABEPRAZOLE SODIUM rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 078964 ANDA medsource pharmaceuticals 45865-802 45865-802-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-60)

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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