Details for New Drug Application (NDA): 020987

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NDA 020987 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 suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

Summary for 020987

Tradename:	PROTONIX
Applicant:	Wyeth Pharms
Ingredient:	pantoprazole sodium
Patents:	0

Pharmacology for NDA: 020987

Mechanism of Action	Proton Pump Inhibitors

Suppliers and Packaging for NDA: 020987

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0841	0008-0841-81	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0841-81)
PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0843	0008-0843-81	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0843-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Feb 2, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 12, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020987

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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