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Generated: September 24, 2017

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 Jubilant Generics, Apotex Inc, Amneal Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Perrigo R And D, Wockhardt, Aurobindo Pharma Ltd, Orchid Hlthcare, Teva, Sun Pharm Inds Ltd, Exela Pharma Scs Llc, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty-one NDAs. It is available from fifty-seven 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 suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for NDA: 205675

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
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)

Summary 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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