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Serving leading biopharmaceutical companies globally:

US Army
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200794

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NDA 200794 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 200794

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

Pharmacology for NDA: 200794

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 200794

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 200794 ANDA Ranbaxy Pharmaceuticals Inc. 63304-967 63304-967-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-967-10)
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 200794 ANDA Ranbaxy Pharmaceuticals Inc. 63304-967 63304-967-77 100 TABLET, DELAYED RELEASE in 1 CARTON (63304-967-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:May 2, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:May 2, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Harvard Business School
Cerilliant
Fuji
Chubb
Teva
Novartis
Daiichi Sankyo
AstraZeneca

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