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General MedicationsORALStandard

FENOFIBRIC ACID

CHOLINE FENOFIBRATE

Standard Dose
EQ 135MG FENOFIBRIC ACID
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FENOFIBRIC ACID is listed in Drugs@FDA under application 213450 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CHOLINE FENOFIBRATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - EQ 135MG FENOFIBRIC ACID Sponsor MICRO LABS Submission history Latest submission status date: 2023-07-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview FENOFIBRIC ACID is listed in Drugs@FDA under application 213450 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CHOLINE FENOFIBRATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - EQ 135MG FENOFIBRIC ACID Sponsor MICRO LABS Submission history Latest submission status date: 2023-07-19 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.