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Last Updated: November 21, 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
Pharmacology for NDA: 018651
Medical Subject Heading (MeSH) Categories for 018651
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 AUTHORIZED GENERIC 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 AUTHORIZED GENERIC 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:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:May 31, 1985TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:May 31, 1985TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 31, 1985TE:ABRLD:Yes

Expired US Patents for NDA 018651

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

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