APPLICATION
ANDA203820
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-22
LATEST ACTION
2019-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
REPAGLINIDEPrescription
REPAGLINIDE 2MG · TABLET · ORAL
REPAGLINIDEPrescription
REPAGLINIDE 0.5MG · TABLET · ORAL
REPAGLINIDEPrescription
REPAGLINIDE 1MG · TABLET · ORAL
Approval history
2019-10-28Labeling · Supplement 7 · standardAP
2019-10-28Labeling · Supplement 4 · standardAP
2014-01-22UNKNOWN · OriginalAP
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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