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FDA Approval

Dronabinol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Major Pharmaceuticals
DUNS: 191427277
Effective Date
December 15, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dronabinol(2.5 mg in 1 1)

Products2

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
0904-7144
Application Number
NDA018651
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 31, 2021
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 7J8897W37SClass: ACTIBQuantity: 2.5 mg in 1 1

Dronabinol

Product Details

NDC Product Code
0904-7145
Application Number
NDA018651
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 31, 2021
Code: 7J8897W37SClass: ACTIBQuantity: 5 mg in 1 1
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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