Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208246

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XELJANZ XR (TOFACITINIB CITRATE)
EQ 11MG BASE
Marketing Status: Prescription
Active Ingredient: TOFACITINIB CITRATE
Proprietary Name: XELJANZ XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 11MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N208246
Product Number: 001
Approval Date: Feb 23, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
XELJANZ XR (TOFACITINIB CITRATE)
EQ 22MG BASE
Marketing Status: Prescription
Active Ingredient: TOFACITINIB CITRATE
Proprietary Name: XELJANZ XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 22MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N208246
Product Number: 002
Approval Date: Dec 12, 2019
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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