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Details for New Drug Application (NDA): 203024

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NDA 203024 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Jubilant Generics, Apotex Inc, Amneal Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Perrigo R And D, Wockhardt, Aurobindo Pharma Ltd, Orchid Hlthcare, Teva, Sun Pharma Global, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty NDAs. It is available from fifty-five suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-six drug master file entries for this compound. Sixty suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for NDA: 203024

Perrigo R And D
pantoprazole sodium
Therapeutic Class:Gastrointestinal Agents

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:May 7, 2014TE:ABRLD:No

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