FDA Orange Book · active-ingredient family
Acetaminophen; butalbital; caffeine; codeine phosphate
Acetaminophen; butalbital; caffeine; codeine phosphate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FIORICET W/ CODEINE · NDA 020232
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FIORICET W/ CODEINERLD | ACTAVIS LABS UT INC | NDA 020232 | AB | Jul 30, 1992 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE×2 | HIKMA | ANDA 215138 | AB | Jan 26, 2022 | |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | QUAGEN | ANDA 204649 | — | Jul 08, 2020 | |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE×2 | LGM PHARMA | ANDA 076560 | AB | Jul 19, 2012 | |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ABLE | ANDA 076528 | — | Aug 21, 2003 | |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | PHARMOBEDIENT | ANDA 075929 | — | Apr 22, 2002 | |
| PHRENILIN WITH CAFFEINE AND CODEINE | VALEANT | ANDA 074911 | — | Aug 22, 2001 | |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | HIKMA INTL PHARMS | ANDA 075618 | — | Mar 23, 2001 |
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.
Acetaminophen; butalbital; caffeine; codeine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
