Orange Book product · Generic (ANDA)
FENTANYL-100
FENTANYL
At a glance
Jan 24, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2023
3 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL
Strength
100MCG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
ANDA 209655
Product number
008
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FENTANYL
- 2012SUBSYSBrand (NDA)
NDA 202788 · BTCP PHARMA
- 1990DURAGESIC-100Brand (NDA)
NDA 019813 · JANSSEN PHARMS
- 2016FENTANYL-100Generic (ANDA)
ANDA 202097 · KINDEVA
- 2011FENTANYL-100Generic (ANDA)
ANDA 077154 · SPECGX LLC
- 2009FENTANYL-100Generic (ANDA)
ANDA 077775 · NOVEN
- 2008FENTANYL-100Generic (ANDA)
ANDA 077449 · DIFGEN PHARMS
- 2007FENTANYL-100Generic (ANDA)
ANDA 076709 · ACTAVIS LABS UT INC
- 2007FENTANYL-100Generic (ANDA)
ANDA 077062 · MAYNE PHARMA
- 2006FENTANYL-100Generic (ANDA)
ANDA 077051 · LAVIPHARM LABS
- 2005FENTANYL-100Generic (ANDA)
ANDA 076258 · MYLAN TECHNOLOGIES
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.
