Orange Book product · Brand (NDA)
FIORINAL W/CODEINE
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
At a glance
Oct 26, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 26, 1990
36 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength
325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 019429
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2015BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 203335 · DR REDDYS LABS SA
- 2001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075231 · LGM PHARMA
- 1999BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 075351 · NOVITIUM 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.
