APPLICATION
ANDA209504
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-30
LATEST ACTION
2022-05-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 200MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 67MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 134MG · CAPSULE · ORAL
Approval history
2022-05-25Labeling · Supplement 10 · standardAP
2019-05-15Labeling · Supplement 4 · standardAP
2019-05-13Labeling · Supplement 2 · standardAP
2018-04-30UNKNOWN · Original · 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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