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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 208580

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NDA 208580 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 208580

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Norvium Bioscience
Ingredient:	pantoprazole sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	May 4, 2018	TE:		RLD:	No

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