➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Boehringer Ingelheim
Baxter
Johnson and Johnson
Mallinckrodt

Last Updated: June 23, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077056


Email this page to a colleague

« Back to Dashboard

NDA 077056 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Sun Pharm, Akorn, Aurobindo Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, Hikma, Actavis Totowa, Amneal Pharms, Atlantide, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Rubicon, Sun Pharm Inds Ltd, Teva, and Torrent Pharms, and is included in twenty-five NDAs. It is available from fifty 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. Fifty-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 077056
Tradename:PANTOPRAZOLE SODIUM
Applicant:Teva
Ingredient:pantoprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077056
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 077056
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 077056 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-343 43353-343-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-30)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 077056 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-343 43353-343-53 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-53)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Aug 2, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Aug 2, 2007TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Johnson and Johnson
Colorcon
Boehringer Ingelheim
Harvard Business School

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 verification 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.