Orange Book product · Generic (ANDA)
DRONABINOL
DRONABINOL
Generic (ANDA)ANDA 201463DISCN LANNETT CO INC
At a glance
May 18, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 2018
8 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DRONABINOL
Strength
2.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 201463
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DRONABINOL
- 2017SYNDROSBrand (NDA)
NDA 205525 · WELLHOUSE PHARMA
- 1985MARINOLBrand (NDA)
NDA 018651 · ALKEM LABS LTD
- 2020DRONABINOLGeneric (ANDA)
ANDA 207421 · ASCENT PHARMS 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.
