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Last Updated: November 2, 2024

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 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 ActionProton 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:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Nov 14, 2007TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 7, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Mar 30, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Mar 30, 2025Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022020

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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