Orange Book product · Brand (NDA)
FENTANYL CITRATE
FENTANYL CITRATE
At a glance
Jan 20, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 20, 2023
3 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 0.025MG BASE/0.5ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019101
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2023FENTANYL CITRATEBrand (NDA)
NDA 215870 · EXELA PHARMA
- 2011LAZANDABrand (NDA)
NDA 022569 · BTCP PHARMA
- 2011ABSTRALBrand (NDA)
NDA 022510 · SENTYNL THERAPS INC
- 2009ONSOLISBrand (NDA)
NDA 022266 · ADALVO
- 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
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.
