Orange Book product · Generic (ANDA)
BUTALBITAL, ASPIRIN AND CAFFEINE
ASPIRIN; BUTALBITAL; CAFFEINE
At a glance
Jun 13, 2007
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 13, 2007
19 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE
Strength
325MG;50MG;40MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
ANDA 078149
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ASPIRIN; BUTALBITAL; CAFFEINE
- 1986FIORINALBrand (NDA)
NDA 017534 · ALLERGAN
- 2021BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 205230 · LGM PHARMA
- 2016BUTALBITAL, ASPIRIN AND CAFFEINEGeneric (ANDA)
ANDA 204195 · STRIDES 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.
