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Details for New Drug Application (NDA): 078501

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NDA 078501 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: 078501

Tradename:
DRONABINOL
Applicant:
Insys Therap
Ingredient:
dronabinol
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078501

Ingredient-typeCannabinoids

Suppliers and Packaging for NDA: 078501

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DRONABINOL
dronabinol
CAPSULE;ORAL 078501 ANDA Mylan Pharmaceuticals Inc. 0378-8170 0378-8170-91 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, UNIT-DOSE (0378-8170-91)
DRONABINOL
dronabinol
CAPSULE;ORAL 078501 ANDA Mylan Pharmaceuticals Inc. 0378-8171 0378-8171-91 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, UNIT-DOSE (0378-8171-91)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Aug 19, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 19, 2011TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Aug 19, 2011TE:RLD:No


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