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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 090970

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NDA 090970 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, Pharmobedient, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Apotex, 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, and Baxter Hlthcare Corp, and is included in forty-three NDAs. It is available from sixty-four 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-six suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 090970

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Mylan Pharms Inc
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 090970

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 090970

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090970	ANDA	Mylan Pharmaceuticals Inc.	0378-6688	0378-6688-77	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6688-77)
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090970	ANDA	Mylan Pharmaceuticals Inc.	0378-6689	0378-6689-10	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 19, 2011	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:	Jan 19, 2011	TE:	AB	RLD:	No

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