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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216878

TOFACITINIB CITRATE (TOFACITINIB CITRATE)
EQ 1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: TOFACITINIB CITRATE
Proprietary Name: TOFACITINIB CITRATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A216878
Product Number: 001
Approval Date: Sep 25, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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