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Serving leading biopharmaceutical companies globally:

McKesson
Deloitte
UBS
Cantor Fitzgerald
Cerilliant
McKinsey
Harvard Business School
QuintilesIMS
Argus Health
Teva

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202038

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NDA 202038 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-two suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 202038
Tradename:PANTOPRAZOLE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202038
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 202038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202038 ANDA PD-Rx Pharmaceuticals, Inc. 43063-618 43063-618-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-618-30)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202038 ANDA Safecor Health, LLC 48433-310 48433-310-10 100 POUCH in 1 BOX, UNIT-DOSE (48433-310-10) > 1 TABLET, DELAYED RELEASE in 1 POUCH (48433-310-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Baxter
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McKinsey
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Federal Trade Commission
Moodys
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