FENOFIBRIC ACID DELAYED-RELEASE CAPSULES

Route
Oral
Dosage form
Capsules
Strength
45mg and 135mg
Rx/OTC
Rx
Indication
Adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia.
TE Rating
AB
Reference Listed Drug
Triplix®
ANDA#
210469
Strength Form Product Description Imprint Image How Supplied NDC Number HDMA
Sheets
PI SDS
45mg Delayed-release capsules 45 mg have a burnt umber opaque cap imprinted with “TWi T109” in white ink and a mustard opaque body imprinted with “45mg” in black ink. “TWi T109” in white ink and a mustard opaque body imprinted with “45mg” in black ink. Bottle of 90 24979-109-07
135mg Delayed-release capsules 135 mg have a blue opaque cap imprinted with “TWi T112” in white ink and a yellow opaque body imprinted with “135mg” in black ink. “TWi T112” in white ink and a yellow opaque body imprinted with “135mg” in black ink. Bottle of 90 24979-112-07

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