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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216171

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NDA 216171 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-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 216171

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Be Pharms
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 216171

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 216171

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	216171	ANDA	BE Pharmaceuticals Inc.	71839-122	71839-122-01	1 VIAL in 1 CARTON (71839-122-01) / 10 mL in 1 VIAL
PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	216171	ANDA	BE Pharmaceuticals Inc.	71839-122	71839-122-10	10 CARTON in 1 PACKAGE (71839-122-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	May 18, 2022	TE:	AP	RLD:	No

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