FDA Orange Book · active-ingredient family
Aspirin; butalbital; caffeine; codeine phosphate
Aspirin; butalbital; caffeine; codeine phosphate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FIORINAL W/CODEINE · NDA 019429
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FIORINAL W/CODEINERLD | ALLERGAN | NDA 019429 | — | Oct 26, 1990 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | DR REDDYS LABS SA | ANDA 203335 | — | Oct 30, 2015 | |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | LGM PHARMA | ANDA 075231 | AB | Nov 30, 2001 | |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | NOVITIUM PHARMA | ANDA 075351 | — | Mar 05, 1999 | |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | STEVENS J | ANDA 074951 | AB | Aug 31, 1998 | |
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | WATSON LABS | ANDA 074359 | — | Aug 31, 1995 |
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.
Aspirin; butalbital; caffeine; codeine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
