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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 201463

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NDA 201463 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 201463

Tradename:	DRONABINOL
Applicant:	Lannett Co Inc
Ingredient:	dronabinol
Patents:	0

Medical Subject Heading (MeSH) Categories for 201463

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:	May 18, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	May 18, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	May 18, 2018	TE:		RLD:	No

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