Orange Book product · Brand (NDA)
LAZANDA
FENTANYL CITRATE
At a glance
Jun 30, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 30, 2011
15 yr 2 mo ago
Today
Patent 9731869 expires
Listed drug product patent expiration.
Jan 26, 2032
in 5 yr 8 mo
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 022569
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 215870 · EXELA PHARMA
- 2023FENTANYL CITRATEBrand (NDA)
NDA 019101 · HIKMA
- 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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9731869 | Jan 26, 2032 | in 5 yr 8 mo | Product |
