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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 076885

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NDA 076885 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Norvium Bioscience, 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 076885

Tradename:	RABEPRAZOLE SODIUM
Applicant:	Norvium Bioscience
Ingredient:	rabeprazole sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 076885

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Nov 8, 2013	TE:		RLD:	No

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