APPLICATION
ANDA077461
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-09
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NATEGLINIDEPrescription
NATEGLINIDE 60MG · TABLET · ORAL
NATEGLINIDEPrescription
NATEGLINIDE 120MG · TABLET · ORAL
Approval history
2023-01-17Labeling · Supplement 6 · standardAP
2018-11-30Labeling · Supplement 4 · standardAP
2018-11-30Labeling · Supplement 3 · standardAP
2015-08-18Labeling · Supplement 1AP
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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