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Last Updated: November 22, 2024

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. 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. Seventy-one 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:0
Pharmacology for NDA: 020988
Mechanism of ActionProton 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;INTRAVENOUS 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;INTRAVENOUS 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:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 22, 2001TE:APRLD:Yes
Regulatory Exclusivity Expiration:Aug 12, 2027
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 020988

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