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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Federal Trade Commission
Farmers Insurance
Chubb
Fish and Richardson
Harvard Business School
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Johnson and Johnson
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090074

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NDA 090074 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-eight 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 090074
Tradename:PANTOPRAZOLE SODIUM
Applicant:Torrent Pharms
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090074
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 090074
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090074 ANDA Major Pharmaceuticals 0904-6474 0904-6474-61 100 TABLET, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0904-6474-61)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090074 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-096 13668-096-74 100 TABLET, DELAYED RELEASE in 1 CARTON (13668-096-74)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
McKinsey
Citi
Cerilliant
Julphar
Farmers Insurance
US Army
Cantor Fitzgerald
Boehringer Ingelheim

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