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Generated: November 18, 2018

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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 eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XELJANZ profile page.

The generic ingredient in XELJANZ is tofacitinib citrate. There are eleven 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 203214
Tradename:XELJANZ
Applicant:Pf Prism Cv
Ingredient:tofacitinib citrate
Patents:7
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 0069-1001-03 28 TABLET, FILM COATED in 1 BOTTLE (0069-1001-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 6, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2020
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO METHOTREXATE OR OTHER NON-BIOLOGIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS
Regulatory Exclusivity Expiration:May 30, 2021
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC)
Patent:➤ Sign UpPatent Expiration:Dec 8, 2020Product Flag?YSubstance Flag?Delist Request?

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