Details for New Drug Application (NDA): 022020

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NDA 022020 describes PROTONIX, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PROTONIX profile page.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 022020

Tradename:	PROTONIX
Applicant:	Wyeth Pharms
Ingredient:	pantoprazole sodium
Patents:	4

Pharmacology for NDA: 022020

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022020

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0844	0008-0844-02	30 PACKET in 1 CARTON (0008-0844-02) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01)
PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020	NDA	Cardinal Health 107, LLC	55154-4232	55154-4232-0	10 PACKET in 1 BAG (55154-4232-0) / 40 GRANULE, DELAYED RELEASE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Nov 14, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 7, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Mar 30, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022020

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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