← FDA DRUG APPROVALS

FDA NDA · NDA216203

INPEFA

sotagliflozin

Sponsor: LEXICON PHARMS INC

APPLICATION
NDA216203
TYPE
NDA
ORIGINAL APPROVAL
2023-05-26
LATEST ACTION
2023-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

INPEFA · ReferencePrescription
SOTAGLIFLOZIN 400MG · TABLET · ORAL
INPEFA · ReferencePrescription
SOTAGLIFLOZIN 200MG · TABLET · ORAL

Approval history

2023-05-26Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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