SYNDROS
These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS (dronabinol) oral solution, CII Initial U.S. Approval: 1985
Approved
Approval ID
c2bc83c1-f9fe-11e2-b778-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2019
Manufacturers
FDA
Insys Therapeutics, Inc.
DUNS: 929033959
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code20482-335
Application NumberNDA205525
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (1)
DRONABINOLActive
Quantity: 5 mg in 1 mL
Code: 7J8897W37S
Classification: ACTIB