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Last Updated: June 12, 2021

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 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 205675
Tradename:PANTOPRAZOLE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:pantoprazole sodium
Patents:0
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 55150-202-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00)
PANTOPRAZOLE SODIUM pantoprazole sodium INJECTABLE;IV (INFUSION) 205675 ANDA AuroMedics Pharma LLC 55150-202 55150-202-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00)

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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