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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207421


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NDA 207421 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 207421
Tradename:DRONABINOL
Applicant:Ascent Pharms Inc
Ingredient:dronabinol
Patents:0
Pharmacology for NDA: 207421
Medical Subject Heading (MeSH) Categories for 207421
Suppliers and Packaging for NDA: 207421
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRONABINOL dronabinol CAPSULE;ORAL 207421 ANDA Lannett Company, Inc. 0527-4125 0527-4125-35 60 CAPSULE in 1 BOTTLE (0527-4125-35)
DRONABINOL dronabinol CAPSULE;ORAL 207421 ANDA Camber Pharmaceuticals Inc 31722-960 31722-960-60 60 CAPSULE in 1 BOTTLE (31722-960-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Feb 7, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Feb 7, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Feb 7, 2020TE:ABRLD:No

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