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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 217282

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NDA 217282 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dexcel, Sun Pharm, Alembic, Aspiro, Be Pharms, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Dr Reddys Labs Ltd, Granules, Graviti Pharms, 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 Research, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Wockhardt Bio Ag, and Baxter Hlthcare Corp, and is included in forty-three NDAs. It is available from sixty-seven 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-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 217282

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Granules
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 217282

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 217282

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	217282	ANDA	Granules Pharmaceuticals Inc.	70010-190	70010-190-09	90 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-09)
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	217282	ANDA	Granules Pharmaceuticals Inc.	70010-190	70010-190-10	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 11, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Dec 11, 2023	TE:	AB	RLD:	No

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