APPLICATION
ANDA205248
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-06
LATEST ACTION
2024-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NATEGLINIDEPrescription
NATEGLINIDE 60MG · TABLET · ORAL
NATEGLINIDEPrescription
NATEGLINIDE 120MG · TABLET · ORAL
Approval history
2024-08-22Labeling · Supplement 6 · standardAP
2018-11-19Labeling · Supplement 2 · standardAP
2018-11-19Labeling · Supplement 1 · standardAP
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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