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Generated: November 15, 2018

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Details for New Drug Application (NDA): 211288

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NDA 211288 describes VIZIMPRO, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the VIZIMPRO profile page.

The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
Summary for 211288
Tradename:VIZIMPRO
Applicant:Pfizer Inc
Ingredient:dacomitinib
Patents:0
Suppliers and Packaging for NDA: 211288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIZIMPRO dacomitinib TABLET;ORAL 211288 NDA Pfizer Laboratories Div Pfizer Inc 0069-0197 0069-0197-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)
VIZIMPRO dacomitinib TABLET;ORAL 211288 NDA Pfizer Laboratories Div Pfizer Inc 0069-1198 0069-1198-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-1198-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Sep 27, 2018TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Sep 27, 2018TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength45MG
Approval Date:Sep 27, 2018TE:RLD:Yes

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