Last Updated: October 4, 2026

Details for New Drug Application (NDA): 217416

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NDA 217416 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, Shuangcheng, 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-four 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 is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 217416

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Ajanta Pharma Ltd
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 217416

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 217416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	217416	ANDA	Ajanta Pharma USA Inc.	27241-256	27241-256-11	1 FOR SUSPENSION in 1 PACKET (27241-256-11)
PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	217416	ANDA	Ajanta Pharma USA Inc.	27241-256	27241-256-38	30 FOR SUSPENSION in 1 CARTON (27241-256-38)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Feb 9, 2023	TE:	AB	RLD:	No

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