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Generated: December 14, 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 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-eight 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-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 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 43353-569-80 180 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-80)
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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