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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 078501

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NDA 078501 describes DRONABINOL, which is a drug marketed by Ascent Pharms Inc, Hikma, Insys Therap, Lannett Co Inc, and Svc Pharma, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DRONABINOL profile page.

The generic ingredient in DRONABINOL is dronabinol. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

Summary for 078501

Tradename:	DRONABINOL
Applicant:	Insys Therap
Ingredient:	dronabinol
Patents:	0

Medical Subject Heading (MeSH) Categories for 078501

Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Hallucinogens
Psychotropic Drugs

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	Aug 19, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Aug 19, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Aug 19, 2011	TE:		RLD:	No

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