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Last Updated: May 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090074

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NDA 090074 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 090074
Tradename:PANTOPRAZOLE SODIUM
Applicant:Torrent Pharms
Ingredient:pantoprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090074
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 090074
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090074 ANDA Major Pharmaceuticals 0904-6474 0904-6474-45 80 BLISTER PACK in 1 CARTON (0904-6474-45) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 090074 ANDA Major Pharmaceuticals 0904-6474 0904-6474-61 100 BLISTER PACK in 1 CARTON (0904-6474-61) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

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