Orange Book product · Generic (ANDA)
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Jan 26, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2022
4 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
300MG;50MG;40MG;30MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 215138
Product number
002
Marketing status
RX
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
- 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
- 2001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075618 · 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.
