Orange Book product · Brand (NDA)
FIORINAL
ASPIRIN; BUTALBITAL; CAFFEINE
At a glance
Apr 16, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 1986
40 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE
Strength
325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017534
Product number
005
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.
- 2021BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 205230 · LGM PHARMA
- 2016BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 204195 · STRIDES PHARMA
- 2007BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 078149 · MPP PHARMA
- 1986BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 089448 · HALSEY
- 1985LANORINALGeneric (ANDA)
ANDA 086986 · LANNETT
- 1985LANORINALGeneric (ANDA)
ANDA 086996 · SANDOZ
- 1985BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 088972 · QUANTUM PHARMICS
- 1985BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 086231 · WATSON LABS
- 1984BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 085441 · IVAX PHARMS
- 1984BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 086398 · FOSUN PHARMA
- 1984BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 086237 · WATSON LABS
- 1984BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 086162 · HIKMA INTL PHARMS
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.
