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Details for New Drug Application (NDA): 079217

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NDA 079217 describes DRONABINOL, which is a drug marketed by Insys Therap, Akorn Inc, and Svc Pharma, and is included in three NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

Summary for NDA: 079217

Akorn Inc
Therapeutic Class:Antiemetics

Pharmacology for NDA: 079217


Suppliers and Packaging for NDA: 079217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 079217 ANDA Akorn, Inc. 17478-761 17478-761-06 1 BOTTLE in 1 CARTON (17478-761-06) > 60 CAPSULE in 1 BOTTLE
CAPSULE;ORAL 079217 ANDA Akorn, Inc. 17478-762 17478-762-06 1 BOTTLE in 1 CARTON (17478-762-06) > 60 CAPSULE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 20, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 20, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 20, 2014TE:ABRLD:No

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