Abstral
Fentanyl Citrate
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 2011
15 yr 9 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
FENTANYL CITRATE
Strength
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 022510
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Other strengths in NDA 022510
- EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET
- EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET
- EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET
- EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET
- EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET
Active-ingredient family
This 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
- 2011LazandaBrand (NDA)
NDA 022569 · Btcp Pharma
- 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
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.
Abstral — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Fentanyl Citrate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
