APPLICATION
ANDA077463
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-09
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NATEGLINIDEPrescription
NATEGLINIDE 120MG · TABLET · ORAL
NATEGLINIDEPrescription
NATEGLINIDE 60MG · TABLET · ORAL
Approval history
2022-10-13Labeling · Supplement 12 · standardAP
2022-10-13Labeling · Supplement 10 · standardAP
2022-10-13Labeling · Supplement 9 · standardAP
2013-07-30Labeling · Supplement 1AP
2013-07-30Labeling · Supplement 5AP
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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