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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Deloitte
Express Scripts
Teva
Moodys
Cerilliant
Merck
Federal Trade Commission
Colorcon

Generated: June 18, 2018

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, Mylan Labs Ltd, Sandoz Inc, Exela Pharma Scs Llc, Actavis Totowa, Amneal Pharms, Apotex Inc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Jubilant Generics, Lannett Co Inc, 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-two 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-three suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 205119
Tradename:PANTOPRAZOLE SODIUM
Applicant:Amneal Pharms
Ingredient:pantoprazole sodium
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 N 43353-569-30
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 205119 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-569 N 43353-569-53

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Boehringer Ingelheim
Argus Health
US Department of Justice
Baxter
Express Scripts
Johnson and Johnson
Cerilliant

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