APPLICATION
ANDA205566
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-07
LATEST ACTION
2021-06-03
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
2021-06-03Labeling · Supplement 5 · standardAP
2019-05-15Labeling · Supplement 3 · standardAP
2018-05-18Labeling · Supplement 2 · standardAP
2017-04-07UNKNOWN · 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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