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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090901

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NDA 090901 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-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 090901
Tradename:PANTOPRAZOLE SODIUM
Applicant:Jubilant Generics
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090901
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 090901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090901 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-283 N 59746-283-30
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090901 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-283 N 59746-283-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Aug 30, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Aug 30, 2011TE:ABRLD:No

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