FDA.reportPublic FDA data

DRONABINOL - Food and Drug Administration

Set ID
03fbef77-e64f-4d6b-9d24-bfd1671e5179
Type
Indexing - product concept
Effective date
2019-04-02
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use dronabinol capsules safely and effectively. See full prescribing information for dronabinol capsules. Dronabinol capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameMajor Pharmaceuticals2026-05-13
These highlights do not include all the information needed to use dronabinol capsules safely and effectively. See full prescribing information for dronabinol capsules. Dronabinol capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameAscend Laboratories, LLC | Patheon Softgels Inc | Apace Packaging LLC | Nutra-Med Packaging Inc.2026-05-06
These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985Product nameBenuvia Operations, LLC2026-04-21
These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985Product nameWellhouse Pharma, LLC2026-04-17
These highlights do not include all the information needed to use DRONABINOL CAPSULES safely and effectively. See full prescribing information for DRONABINOL CAPSULES. DRONABINOL capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameCamber Pharmaceuticals Inc | Ascent Pharmaceuticals Inc2026-04-13
These highlights do not include all the information needed to use DRONABINOL ORAL SOLUTION safely and effectively. See full prescribing information for DRONABINOL ORAL SOLUTION. DRONABINOL Oral Solution, CII Initial U.S. Approval: 1985Product nameWellhouse Pharma, LLC | Benuvia Operations, LLC2026-02-11
These highlights do not include all the information needed to use DRONABINOL ORAL SOLUTION safely and effectively. See full prescribing information for DRONABINOL ORAL SOLUTION. DRONABINOL Oral Solution, CII Initial U.S. Approval: 1985Product nameChartwell RX, LLC2026-01-26
These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985Product nameBenuvia Operations, LLC2026-01-26
These highlights do not include all the information needed to use DRONABINOL CAPSULES, USP safely and effectively. See full prescribing information for DRONABINOL CAPSULES, USP. DRONABINOL CAPSULES, USP for oral use, CIII Initial U.S. Approval: 1985Product nameAmerican Health Packaging2025-01-07
These highlights do not include all the information needed to use DRONABINOL CAPSULES safely and effectively. See full prescribing information for DRONABINOL CAPSULES. DRONABINOL capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameLannett Company, Inc. | Ascent Pharmaceuticals, Inc.2023-06-19
These highlights do not include all the information needed to use MARINOL® safely and effectively. See full prescribing information for MARINOL. MARINOL (dronabinol) capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameThePharmaNetwork, LLC | Patheon Softgels Inc | Mikart, LLC | Apace Packaging LLC | Nutra-Med Packaging Inc.2023-02-14
These highlights do not include all the information needed to use DRONABINOL CAPSULES safely and effectively. See full prescribing information for DRONABINOL CAPSULES. DRONABINOL capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameAkorn | Procaps SA2022-01-25
These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985Product nameInsys Therapeutics, Inc. | Benuvia Therapeutics, Inc.2019-12-11
These highlights do not include all the information needed to use MARINOL ® safely and effectively. See full prescribing information for MARINOL. MARINOL (dronabinol) capsules, for oral use, CIII Initial U.S. Approval: 1985Product nameThePharmaNetwork, LLC | Patheon Softgels Inc2019-04-08
Dronabinol Capsules, USP CIII Rx onlyProduct namePhysicians Total Care, Inc.2012-01-27