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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213426

SEGLENTIS (CELECOXIB; TRAMADOL HYDROCHLORIDE)
56MG;44MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB; TRAMADOL HYDROCHLORIDE
Proprietary Name: SEGLENTIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 56MG;44MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213426
Product Number: 001
Approval Date: Oct 15, 2021
Applicant Holder Full Name: KOWA PHARMACEUTICALS AMERICA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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