USSubmitted label - approval not established

SYNDROS (DRONABINOL) SOLUTION

This is a locally preserved regulatory record. Source labeling does not by itself prove efficacy for a condition.

Submitted product label. A product label is preserved locally, but approval or current marketing status is not established.

Product data

Locally preserved regulatory fields

Active ingredients: dronabinol, syndros
Route: Not reported
Dosage form: Not reported
Marketing holder: INSYS THERAPEUTICS, INC.
Catalog status: Submitted label - approval not established
Source-reported status: Not reported

Linked local records

Related local records

Substance links use source-reported active ingredients. Condition links come from registered study context and are not efficacy claims.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Condition reports

Chronic Pain Multiple Sclerosis Alzheimer Disease Cancer Pain Stress Disorders, Post-Traumatic Opioid-Related Disorders Bipolar Disorder

Regulatory record

Approval, patents and exclusivity

Patent and exclusivity fields are preserved from the regulator. They are not a legal opinion and are separate from clinical development.

0approval records

0source-reported patents

0exclusivity records

Clinical development

Related registered studies

Phases and statuses are source-reported study stages matched by governed token phrases. They do not prove medicine identity, approval or efficacy.

140candidate study links

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 5 mg dronabinol + 125 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

DRUG · IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide

Obstructive Sleep Apnea (OSA)

PHASE2RECRUITING

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

Source-reported use

Indications in regulatory records

No indication text was reported by the connected sources.

Medicine identity matching

RxNorm candidates

RxNorm normalizes identity; FAERS supplies non-causal post-market signals.

Identity candidate · score 14.83644962310791

Syndros

Matched from: SYNDROS (DRONABINOL) SOLUTION

Official RxNorm record

Identity candidate · score 11.548243013334275

cannabinol / dronabinol

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 15.55755927848816

dronabinol 5 MG/ML [Syndros]

Matched from: SYNDROS (DRONABINOL) SOLUTION

Official RxNorm record

Identity candidate · score 12.399767059113982

dronabinol Oral Product

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 12.399767059113982

dronabinol Oral Capsule

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 13.219049857385638

Syndros Oral Liquid Product

Matched from: syndros

Official RxNorm record

Identity candidate · score 15.38550422172629

dronabinol 5 MG/ML Oral Solution [Syndros]

Safety signals

Locally preserved FAERS reports

7,900reports

5,906reported as serious

FAERS/AEMS reports are post-market signals. Counts do not establish causality or incidence and may contain duplicates or reporting bias.

Sources and provenance

Official source snapshots

DailyMed structured labels

c2bc83c1-f9fe-11e2-b778-0800200c9a66 · version 12

Retrieved 22/08/2026, 21:20:19Verify at source

Locally preserved regulatory fields

Related local records

Cannabinoids and active compounds

Condition reports

Approval, patents and exclusivity

Related registered studies

Indications in regulatory records

RxNorm candidates

Syndros

cannabinol / dronabinol

dronabinol 5 MG/ML [Syndros]

dronabinol Oral Product

dronabinol Oral Capsule

Syndros Oral Liquid Product

dronabinol 5 MG/ML Oral Solution [Syndros]

Locally preserved FAERS reports

Official source snapshots

DailyMed structured labels

dronabinol Oral Solution [Syndros]

Syndros Oral Product

dronabinol Oral Solution

Dronabinol

dronabinol Pill

dronabinol Oral Liquid Product

RxNorm concept