Orange Book product · Generic (ANDA)
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Mar 23, 2001
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2001
25 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
325MG;50MG;40MG;30MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 075618
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
- 1992FIORICET W/ CODEINEBrand (NDA)
NDA 020232 · ACTAVIS LABS UT INC
- 2022BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 215138 · HIKMA
- 2020BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 204649 · QUAGEN
- 2012BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 076560 · LGM PHARMA
- 2003BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 076528 · ABLE
- 2002BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075929 · PHARMOBEDIENT
- 2001PHRENILIN WITH CAFFEINE AND CODEINEGeneric (ANDA)
ANDA 074911 · VALEANT
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.
