USFDA approved

DRONABINOL

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

Regulatory product record. The connected regulator reports this product as approved, authorised or currently marketed.

Product data

Locally preserved regulatory fields

Active ingredients: DRONABINOL
Route: ORAL
Dosage form: CAPSULE
Marketing holder: HIKMA PHARMACEUTICALS USA INC
Catalog status: FDA approved
Source-reported status: FDA approved

Medicine name group

4 preserved variants

Records share the same exact normalized name. Different identifiers, strengths, countries, presentations and statuses remain separate.

FDA approvedUSCurrent record

DRONABINOL

2.5MG

ORAL · CAPSULE

5 identifiers · Drugs@FDA application data · FDA Orange Book

FDA approvedUS

DRONABINOL

2.5MG

ORAL · CAPSULE

5 identifiers · Drugs@FDA application data · FDA Orange Book

FDA approvedUS

DRONABINOL

2.5MG

ORAL · CAPSULE

5 identifiers · Drugs@FDA application data · FDA Orange Book

FDA approvedUS

DRONABINOL

2.5MG

ORAL · CAPSULE

5 identifiers · Drugs@FDA application data · FDA Orange Book

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.

6approval records

0source-reported patents

0exclusivity records

U.S. FDA

FDA approved

Approval / market date · Not reported

U.S. FDA

FDA approved

Approval / market date · Not reported

U.S. FDA

FDA approved

Approval / market date · Not reported

U.S. FDA

FDA approved

Approval / market date · 2014-06-20

U.S. FDA

FDA approved

Approval / market date · 2014-06-20

U.S. FDA

FDA approved

Approval / market date · 2014-06-20

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

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

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 11.548243013334275

cannabinol / dronabinol

Matched from: DRONABINOL

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 12.399767059113982

dronabinol Oral Solution

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 13.336081504821777

Dronabinol

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 12.831381125926972

dronabinol Pill

Matched from: DRONABINOL

Official RxNorm record

Identity candidate · score 12.026340742131776

dronabinol Oral Liquid Product

Matched from: DRONABINOL

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

Drugs@FDA application data

ANDA079217:001 · version d6a5fe5ae6834d4ffa421948a56cd423f489d4c5b0c2849ca3e240439e70d3a0

Retrieved 25/08/2026, 09:57:07Verify at source

Drugs@FDA application data

ANDA079217:002 · version d6a5fe5ae6834d4ffa421948a56cd423f489d4c5b0c2849ca3e240439e70d3a0

Retrieved 25/08/2026, 09:57:07Verify at source

Drugs@FDA application data

ANDA079217:003 · version d6a5fe5ae6834d4ffa421948a56cd423f489d4c5b0c2849ca3e240439e70d3a0

Retrieved 25/08/2026, 09:57:07Verify at source

FDA Orange Book

ANDA079217:001 · version 2026-08-19

Retrieved 20/08/2026, 10:33:18Verify at source

FDA Orange Book

ANDA079217:002 · version 2026-08-19

Retrieved 20/08/2026, 10:33:18Verify at source

FDA Orange Book

ANDA079217:003 · version 2026-08-19

Retrieved 20/08/2026, 10:33:18Verify at source