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Details for New Drug Application (NDA): 203214

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NDA 203214 describes XELJANZ, which is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in two NDAs. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the XELJANZ profile page.

The generic ingredient in XELJANZ is tofacitinib citrate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

Summary for NDA: 203214

Tradename:
XELJANZ
Applicant:
Pf Prism Cv
Ingredient:
tofacitinib citrate
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 203214

Mechanism of ActionJanus Kinase Inhibitors

Suppliers and Packaging for NDA: 203214

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XELJANZ
tofacitinib citrate
TABLET;ORAL 203214 NDA Pfizer Laboratories Div Pfizer Inc 0069-1001 0069-1001-01 60 TABLET, FILM COATED in 1 BOTTLE (0069-1001-01)
XELJANZ
tofacitinib citrate
TABLET;ORAL 203214 NDA Pfizer Laboratories Div Pfizer Inc 0069-1001 0069-1001-02 180 TABLET, FILM COATED in 1 BOTTLE (0069-1001-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 6, 2012TE:RLD:Yes
Patent:6,956,041Patent Expiration:Dec 8, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,965,027Patent Expiration:Mar 25, 2023Product Flag?Substance Flag?YDelist Request?
Patent:7,265,221Patent Expiration:Dec 8, 2020Product Flag?Substance Flag?YDelist Request?


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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.

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