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Details for New Drug Application (NDA): 090074

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NDA 090074 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 Pharma Global, Mylan Pharms Inc, Torrent Pharms, Kremers Urban Pharms, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Sandoz Inc, Akorn Inc, and Actavis Totowa, and is included in twenty NDAs. It is available from fifty-five suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-six drug master file entries for this compound. Sixty suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for NDA: 090074

Tradename:
PANTOPRAZOLE SODIUM
Applicant:
Torrent Pharms
Ingredient:
pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
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 0904-6474-61 100 TABLET, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0904-6474-61)
PANTOPRAZOLE SODIUM
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 090074 ANDA Torrent Pharmaceuticals Limited 13668-096 13668-096-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-096-05)

Summary for product number 001

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

Summary 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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