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Last Updated: March 16, 2025

Details for New Drug Application (NDA): 219087

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NDA 219087 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, 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, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Wockhardt Bio Ag, and Baxter Hlthcare Corp, and is included in thirty-nine 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 219087

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

Pharmacology for NDA: 219087

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 219087

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	219087	ANDA	Rising Pharma Holdings, Inc.	64980-676	64980-676-09	90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-676-09)
PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	219087	ANDA	Rising Pharma Holdings, Inc.	64980-677	64980-677-09	90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-677-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 16, 2025	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 16, 2025	TE:	AB	RLD:	No

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