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Details for New Drug Application (NDA): 202324

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NDA 202324 describes INLYTA, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the INLYTA profile page.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

Summary for NDA: 202324

Pf Prism Cv

Pharmacology for NDA: 202324

Suppliers and Packaging for NDA: 202324

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 202324 NDA Pfizer Laboratories Div Pfizer Inc 0069-0145 0069-0145-01 180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)
TABLET;ORAL 202324 NDA Pfizer Laboratories Div Pfizer Inc 0069-0151 0069-0151-11 60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 27, 2012TE:RLD:No
Patent:6,534,524Patent Expiration:Apr 29, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:8,791,140Patent Expiration:Aug 5, 2030Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jan 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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