Orange Book product · Generic (ANDA)
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Aug 31, 1998
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 1998
28 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
325MG;50MG;40MG;30MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 074951
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 1995BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 074359 · WATSON LABS
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.
