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Serving leading biopharmaceutical companies globally:

Teva
Citi
QuintilesIMS
Harvard Business School
Chubb
Novartis
Moodys
Merck
Covington
McKinsey

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205119

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NDA 205119 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: 205119

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

Pharmacology for NDA: 205119

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 205119

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 205119 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-569 43353-569-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-30)
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 205119 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-569 43353-569-53 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-53)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 26, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Jan 26, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
UBS
Chubb
Covington
Merck
Cerilliant
Medtronic
Farmers Insurance
Express Scripts

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