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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 018651

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NDA 018651 describes MARINOL, which is a drug marketed by Alkem Labs Ltd and is included in one NDA. It is available from four suppliers. Additional details are available on the MARINOL profile page.

The generic ingredient in MARINOL 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 018651

Tradename:	MARINOL
Applicant:	Alkem Labs Ltd
Ingredient:	dronabinol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018651

Medical Subject Heading (MeSH) Categories for 018651

Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Hallucinogens
Psychotropic Drugs

Suppliers and Packaging for NDA: 018651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MARINOL	dronabinol	CAPSULE;ORAL	018651	NDA	Major Pharmaceuticals	0904-7144	0904-7144-61	100 BLISTER PACK in 1 CARTON (0904-7144-61) / 1 CAPSULE in 1 BLISTER PACK
MARINOL	dronabinol	CAPSULE;ORAL	018651	NDA	Major Pharmaceuticals	0904-7145	0904-7145-04	30 BLISTER PACK in 1 CARTON (0904-7145-04) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	May 31, 1985	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	May 31, 1985	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	May 31, 1985	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018651

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-003	May 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-001	May 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Alkem Labs Ltd	MARINOL	dronabinol	CAPSULE;ORAL	018651-002	May 31, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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