Orange Book product · Brand (NDA)
FENTANYL CITRATE
FENTANYL CITRATE
At a glance
Feb 08, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 08, 2023
3 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215870
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 019101 · HIKMA
- 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.
