Orange Book product · Brand (NDA)
ONSOLIS
FENTANYL CITRATE
At a glance
Jul 16, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2009
17 yr 2 mo ago
Today
Patent 9597288 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 1.2MG BASE
Dosage form
FILM
Route
BUCCAL
TE code
Not listed
Application
NDA 022266
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2023FENTANYL CITRATEBrand (NDA)
NDA 215870 · EXELA PHARMA
- 2023FENTANYL CITRATEBrand (NDA)
NDA 019101 · HIKMA
- 2011LAZANDABrand (NDA)
NDA 022569 · BTCP PHARMA
- 2011ABSTRALBrand (NDA)
NDA 022510 · SENTYNL THERAPS INC
- 2006FENTORABrand (NDA)
NDA 021947 · CEPHALON
- 1998ACTIQBrand (NDA)
NDA 020747 · CEPHALON
- 1995FENTANYLBrand (NDA)
NDA 020195 · CEPHALON
- 1985FENTANYL CITRATEBrand (NDA)
NDA 019115 · HOSPIRA
- —SUBLIMAZE PRESERVATIVE FREEBrand (NDA)
NDA 016619 · RISING
- 2022FENTANYL CITRATEGeneric (ANDA)
ANDA 206329 · DR REDDYS LABS SA
- 2020FENTANYL CITRATEGeneric (ANDA)
ANDA 212086 · FRESENIUS KABI USA
- 2019FENTANYL CITRATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 210762 · FRESENIUS KABI USA
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9597288 | Jul 23, 2027 | in 1 yr 1 mo | ProductU-767 |
