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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216247

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NDA 216247 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 216247

Tradename:	PANTOPRAZOLE SODIUM
Applicant:	Dexcel
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 216247

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 216247

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	216247	ANDA	Edenbridge Pharmaceuticals LLC.	42799-952	42799-952-30	30 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jun 16, 2023	TE:	AB	RLD:	No

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