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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

UBS
Cipla
US Department of Justice
Johnson and Johnson
US Army
Colorcon
Federal Trade Commission
Cantor Fitzgerald
Chinese Patent Office
Harvard Business School

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090797

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NDA 090797 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 090797

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

Pharmacology for NDA: 090797

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 090797

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090797 ANDA State of Florida DOH Central Pharmacy 53808-0957 53808-0957-1 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-0957-1)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090797 ANDA Proficient Rx LP 63187-042 63187-042-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-042-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Feb 7, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Feb 7, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
AstraZeneca
Dow
Boehringer Ingelheim
Covington
Merck
Novartis
UBS
Citi
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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