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Details for New Drug Application (NDA): 202882

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NDA 202882 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: 202882

Hetero Labs Ltd V
pantoprazole sodium
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 202882

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 202882

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 202882 ANDA Camber Pharmaceuticals, Inc. 31722-712 31722-712-31 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (31722-712-31)
pantoprazole sodium
TABLET, DELAYED RELEASE;ORAL 202882 ANDA Camber Pharmaceuticals, Inc. 31722-712 31722-712-32 10 TABLET, DELAYED RELEASE in 1 CARTON (31722-712-32)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 10, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 10, 2014TE:ABRLD:No

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