Skip to content
Assyro AI
Orange Book drug · Generic (ANDA)

Fenofibric Acid

Choline Fenofibrate

ANDA 212598 2 strengths Aurobindo Pharma Ltd
Approved
Jul 25, 2019
Strengths
2
Listed patents
0
Applications
12

What does the FDA Orange Book show for Fenofibric Acid?

Fenofibric Acid contains Choline Fenofibrate and appears in 12 FDA Orange Book applications. ANDA 212598 is the lead filing, with 2 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
12; lead ANDA 212598

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Aurobindo Pharma Ltd

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AB

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
0

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASEORALPrescriptionAB
None posted
002EQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASEORALPrescriptionAB
RS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Aurobindo Pharma Ltd

The Orange Book identifies this organization as the applicant responsible for ANDA 212598.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 212598 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule, Delayed Release · Oral

Choline Fenofibrate

13 applications
Product rows
26
Active applications
8
Active with AB row
8
Trilipix · NDA 022224

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-212598

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · ANDA 212598
TE AB
Strength
EQ 45MG FENOFIBRIC ACID
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 1 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

CHOLINE FENOFIBRATE

Strength

EQ 45MG FENOFIBRIC ACID

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 212598

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

No

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Other FDA applications for Fenofibric Acid

11 additional filings · 11 generic

The FDA has approved 12 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Fenofibric Acid, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 200264Impax Labs IncSep 07, 20162ABPrescription
ANDA 200750Chartwell RxDec 04, 20132ABPrescription
ANDA 200913PharmobedientMar 25, 20132—Discontinued
ANDA 200920Actavis ElizabethOct 07, 20152ABPrescription
ANDA 201573Ph HealthJul 18, 20132—Discontinued
ANDA 207796Macleods Pharms LtdFeb 08, 20242—Discontinued
ANDA 208705AlembicMay 12, 20172ABPrescription
ANDA 210469Twi PharmsJul 05, 20192—Discontinued
ANDA 211626RisingJul 18, 20192ABPrescription
ANDA 212562Yichang HumanwellDec 23, 20202ABPrescription
ANDA 213450Micro LabsJun 16, 20202ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Choline Fenofibrate

View full Choline Fenofibrate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Fenofibric Acid: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of ANDA 212598 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo