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Orange Book drug · Brand (NDA)

Iomervu

Iomeprol

RLDNDA 216016 13 strengths Bracco
Approved
Nov 27, 2024
Strengths
13
Listed patents
0
Applications
2

What does the FDA Orange Book show for Iomervu?

Iomervu contains Iomeprol and appears in 2 FDA Orange Book applications. NDA 216016 is the lead filing, with 13 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
2; lead NDA 216016

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

Lead application holder
Bracco Diagnostics Inc

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

Product presentations
13

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

Marketing categories
Discontinued and Prescription

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

Reference roles
RLD / RS

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

TE codes
None posted

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
1

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
00125GM IODINE/100ML (250MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00215GM IODINE/50ML (300MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00330GM IODINE/100ML (300MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00445GM IODINE/150ML (300MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00560GM IODINE/200ML (300MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00617.5GM IODINE/50ML (350MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00735GM IODINE/100ML (350MG IODINE/ML)SOLUTIONINTRA-ARTERIALPrescriptionNone posted
RLDRS
00852.5GM IODINE/150ML (350MG IODINE/MLSOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
00970GM IODINE/200ML (350MG IODINE/ML)SOLUTIONINTRA-ARTERIALPrescriptionNone posted
RLDRS
01020GM IODINE/50ML (400MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
01140GM IODINE/100ML (400MG IODINE/ML)SOLUTIONINTRA-ARTERIALPrescriptionNone posted
RLDRS
01260GM IODINE/150ML (400MG IODINE/ML)SOLUTIONINTRA-ARTERIALDiscontinuedNone posted
RLD
01380GM IODINE/200ML (400MG IODINE/ML)SOLUTIONINTRA-ARTERIALPrescriptionNone posted
RLDRS

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

Bracco Diagnostics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 216016.

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

Status varies by presentation: 9 on the Discontinued Drug Product List and 4 prescription

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

0 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 27, 2029. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs 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

NDA 216016 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intra-arterial

Iomeprol

1 application
Product rows
13
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-216016

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

13 approved presentations · NDA 216016
RLDDiscontinued
Strength
25GM IODINE/100ML (250MG IODINE/ML)
Dosage form
SOLUTION
Route
INTRA-ARTERIAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    1 yr 8 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 3 yr 5 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030TodayExclusivity NCE: 2029-11-27Exclusivity NCE
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

IOMEPROL

Strength

25GM IODINE/100ML (250MG IODINE/ML)

Dosage form

SOLUTION

Route

INTRA-ARTERIAL

TE code

Not listed

Application

NDA 216016

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    in 3 yr 5 mo

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 Iomervu

1 additional filing

The FDA has approved 2 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 Iomervu, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 216017BraccoNov 27, 202413—Discontinued

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Iomeprol 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.

Iomervu: 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 NDA 216016 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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