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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216203

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INPEFA (SOTAGLIFLOZIN)
200MG
Marketing Status: Prescription
Active Ingredient: SOTAGLIFLOZIN
Proprietary Name: INPEFA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216203
Product Number: 001
Approval Date: May 26, 2023
Applicant Holder Full Name: LEXICON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INPEFA (SOTAGLIFLOZIN)
400MG
Marketing Status: Prescription
Active Ingredient: SOTAGLIFLOZIN
Proprietary Name: INPEFA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216203
Product Number: 002
Approval Date: May 26, 2023
Applicant Holder Full Name: LEXICON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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