USSubmitted label - approval not established

DRONABINOL CAPSULE

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
Route: Not reported
Dosage form: Not reported
Marketing holder: PHYSICIANS TOTAL CARE, 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.

139candidate study links

PHASE2 · PHASE3NOT_YET_RECRUITING

Effects Of Cannabis Products On Blood Pressure Control

DRUG · Dronabinol

Blood Pressure

PHASE2TERMINATED

Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder

DRUG · Dronabinol

Cannabis Use Disorder

PHASE2RECRUITING

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee

DRUG · Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)

Osteoarthritis, Knee · Osteoarthritis of the Knee

PHASE3ACTIVE_NOT_RECRUITING

BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

DRUG · Dronabinol 2.5mg Capsule

COPD · Breathlessness · Cannabis

PHASE2 · PHASE3NOT_YET_RECRUITING

Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes

DRUG · Dronabinol

Obstructive Sleep Apnea

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

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 11.546336809015274

cannabinol / dronabinol

Matched from: dronabinol

Official RxNorm record

Identity candidate · score 12.40404172563553