Orange Book product · Generic (ANDA)
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Mar 05, 1999
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 05, 1999
27 yr 8 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 075351
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
- 1998BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 074951 · STEVENS J
- 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.
