Orange Book product · Brand (NDA)
MARINOL
DRONABINOL
At a glance
May 31, 1985
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 1985
41 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DRONABINOL
Strength
2.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 018651
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017SYNDROSBrand (NDA)
NDA 205525 · WELLHOUSE PHARMA
- 2020DRONABINOLGeneric (ANDA)
ANDA 207421 · ASCENT PHARMS INC
- 2018DRONABINOLGeneric (ANDA)
ANDA 201463 · LANNETT CO INC
- 2014DRONABINOLGeneric (ANDA)
ANDA 079217 · HIKMA
- 2011DRONABINOLGeneric (ANDA)
ANDA 078501 · INSYS THERAP
- 2008DRONABINOLGeneric (ANDA)
ANDA 078292 · RHODES
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
