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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202882


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NDA 202882 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Dexcel, Sun Pharm, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Wockhardt Bio Ag, and Baxter Hlthcare Corp, and is included in thirty-eight NDAs. It is available from sixty-nine 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. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 202882
Tradename:PANTOPRAZOLE SODIUM
Applicant:Hetero Labs Ltd V
Ingredient:pantoprazole sodium
Patents:0
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 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 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)

Profile for product number 001

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

Profile 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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