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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


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:Yes
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.