Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dronabinol
Product Details
NDC Product Code
72162-1879Application Number
NDA018651Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
March 30, 2023DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 5 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT