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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Chinese Patent Office
McKesson
Cipla
Novartis
Colorcon
Deloitte
Mallinckrodt
Daiichi Sankyo

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202882

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NDA 202882 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Sandoz Inc, Exela Pharma Scs Llc, Actavis Totowa, Amneal Pharms, Apotex Inc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Jubilant Generics, Kremers Urban Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt, and is included in twenty-one NDAs. It is available from fifty-nine suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-seven drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 202882
Tradename:PANTOPRAZOLE SODIUM
Applicant:Hetero Labs Ltd V
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202882
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 202882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202882 ANDA Camber Pharmaceuticals, Inc. 31722-712 31722-712-32 10 TABLET, DELAYED RELEASE in 1 CARTON (31722-712-32)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202882 ANDA Camber Pharmaceuticals, Inc. 31722-712 31722-712-31 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (31722-712-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 10, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 10, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Federal Trade Commission
QuintilesIMS
Merck
Teva
UBS
Covington
Argus Health

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