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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090901

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NDA 090901 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-eight 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 suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 090901

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Jubilant Generics
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 090901

Mechanism of Action	Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Aug 30, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Aug 30, 2011	TE:		RLD:	No

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