Details for New Drug Application (NDA): 020988

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NDA 020988 describes PROTONIX IV, which is a drug marketed by Wyeth Pharms and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the PROTONIX IV profile page.

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

Summary for 020988

Tradename:	PROTONIX IV
Applicant:	Wyeth Pharms
Ingredient:	pantoprazole sodium
Patents:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020988

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 020988

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROTONIX IV	pantoprazole sodium	INJECTABLE;IV (INFUSION)	020988	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0923	0008-0923-51	1 VIAL in 1 CARTON (0008-0923-51) > 10 mL in 1 VIAL
PROTONIX IV	pantoprazole sodium	INJECTABLE;IV (INFUSION)	020988	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0923	0008-0923-55	10 CARTON in 1 PACKAGE (0008-0923-55) > 1 VIAL in 1 CARTON > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;IV (INFUSION)			Strength	EQ 40MG BASE/VIAL
Approval Date:	Mar 22, 2001	TE:	AP	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	May 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	➤ Sign Up	Patent Expiration:	May 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	➤ Sign Up	Patent Expiration:	May 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020988

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;IV (INFUSION)	020988-001	Mar 22, 2001	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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