Orange Book product · Generic (ANDA)
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Aug 31, 1995
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 1995
31 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
325MG;50MG;40MG;30MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 074359
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; CODEINE PHOSPHATE
- 1990FIORINAL W/CODEINEBrand (NDA)
NDA 019429 · ALLERGAN
- 2015BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 203335 · DR REDDYS LABS SA
- 2001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075231 · LGM PHARMA
- 1999BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075351 · NOVITIUM PHARMA
- 1998BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 074951 · STEVENS J
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.
