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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202038


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NDA 202038 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Dexcel, Sun Pharm, Acic Pharms, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Knack, Meitheal, Mylan Labs Ltd, Sandoz, 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, and Wockhardt Bio Ag, and is included in thirty-six NDAs. It is available from sixty-six 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. Sixty-seven suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 202038
Tradename:PANTOPRAZOLE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:pantoprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202038
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 202038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202038 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8113 0615-8113-05 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-05)
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 202038 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8113 0615-8113-39 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 28, 2012TE:ABRLD:No

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