Orange Book product · Generic (ANDA)
FENTANYL CITRATE PRESERVATIVE FREE
FENTANYL CITRATE
At a glance
May 03, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 03, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 0.05MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 210762
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FENTANYL CITRATE
- 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
- 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
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.
