Orange Book product · Generic (ANDA)
BUTALBITAL, ASPIRIN AND CAFFEINE
ASPIRIN; BUTALBITAL; CAFFEINE
At a glance
Oct 18, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE
Strength
500MG;50MG;40MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 205230
Product number
001
Marketing status
DISCN
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
- 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.
