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Serving leading biopharmaceutical companies globally:

Deloitte
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Fuji
Farmers Insurance
Colorcon
Dow
US Department of Justice
AstraZeneca
Johnson and Johnson
Fish and Richardson

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205675

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NDA 205675 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-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-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 205675
Tradename:PANTOPRAZOLE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205675
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 205675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;IV (INFUSION) 205675 ANDA AuroMedics Pharma LLC 55150-202 N 55150-202-25
PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;IV (INFUSION) 205675 ANDA AuroMedics Pharma LLC 55150-202 N 55150-202-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 40MG BASE/VIAL
Approval Date:Mar 30, 2016TE:APRLD:No

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