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Details for New Drug Application (NDA): 208246

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NDA 208246 describes XELJANZ XR, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the XELJANZ XR profile page.

The generic ingredient in XELJANZ XR 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: 208246

Tradename:
XELJANZ XR
Applicant:
Pfizer Inc
Ingredient:
tofacitinib citrate
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 208246

Mechanism of ActionJanus Kinase Inhibitors

Suppliers and Packaging for NDA: 208246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL 208246 NDA Pfizer Laboratories Div Pfizer Inc 0069-0501 0069-0501-14 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-14)
XELJANZ XR
tofacitinib citrate
TABLET, EXTENDED RELEASE;ORAL 208246 NDA Pfizer Laboratories Div Pfizer Inc 0069-0501 0069-0501-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 11MG BASE
Approval Date:Feb 23, 2016TE: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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