Orange Book product · Generic (ANDA)
FENTANYL-100
FENTANYL
At a glance
Jan 28, 2005
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2005
21 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL
Strength
100MCG/HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB
Application
ANDA 076258
Product number
004
Marketing status
RX
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
- 2023FENTANYL-100Generic (ANDA)
ANDA 209655 · ZYDUS 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
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.
