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Generated: March 25, 2019

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Details for New Drug Application (NDA): 211651

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NDA 211651 describes TALZENNA, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the TALZENNA profile page.

The generic ingredient in TALZENNA is talazoparib tosylate. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.
Summary for 211651
Tradename:TALZENNA
Applicant:Pfizer Inc
Ingredient:talazoparib tosylate
Patents:4
Generic Entry Opportunity Date for 211651
Generic Entry Date for 211651*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 211651
Suppliers and Packaging for NDA: 211651
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TALZENNA talazoparib tosylate CAPSULE;ORAL 211651 NDA Pfizer Laboratories Div Pfizer Inc 0069-0296 0069-0296-30 30 CAPSULE in 1 BOTTLE (0069-0296-30)
TALZENNA talazoparib tosylate CAPSULE;ORAL 211651 NDA Pfizer Laboratories Div Pfizer Inc 0069-1195 0069-1195-30 30 CAPSULE in 1 BOTTLE (0069-1195-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.25MG BASE
Approval Date:Oct 16, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 19, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Jul 27, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Oct 20, 2031Product Flag?YSubstance Flag?YDelist Request?

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