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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077058

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NDA 077058 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 Pharm Inds Ltd, Exela Pharma Scs Llc, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sandoz Inc, Akorn Inc, and Actavis Totowa, 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 NDA: 077058

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077058

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 077058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 077058 ANDA Rebel Distributors Corp 42254-124 42254-124-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (42254-124-30)
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 077058 ANDA Sun Pharma Global FZE 47335-144 47335-144-81 90 TABLET, DELAYED RELEASE in 1 BOTTLE (47335-144-81)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 10, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 10, 2007TE:RLD:No


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