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FDA Orange Book · active-ingredient family

Aspirin; butalbital; caffeine

Aspirin; butalbital; caffeine is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FIORINAL · NDA 017534

1

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
FIORINALRLD×2ALLERGANNDA 017534—Apr 16, 1986

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
BUTALBITAL, ASPIRIN AND CAFFEINELGM PHARMAANDA 205230—Oct 18, 2021
BUTALBITAL, ASPIRIN AND CAFFEINESTRIDES PHARMAANDA 204195—Sep 22, 2016
BUTALBITAL, ASPIRIN AND CAFFEINEMPP PHARMAANDA 078149AAJun 13, 2007
BUTALBITAL, ASPIRIN AND CAFFEINEHALSEYANDA 089448—Dec 01, 1986
LANORINALLANNETTANDA 086986—Oct 18, 1985
LANORINALSANDOZANDA 086996AAOct 11, 1985
BUTALBITAL, ASPIRIN AND CAFFEINEQUANTUM PHARMICSANDA 088972—Jun 18, 1985
BUTALBITAL, ASPIRIN AND CAFFEINEWATSON LABSANDA 086231—Feb 12, 1985
BUTALBITAL, ASPIRIN AND CAFFEINEIVAX PHARMSANDA 085441—Oct 31, 1984
BUTALBITAL, ASPIRIN AND CAFFEINEFOSUN PHARMAANDA 086398—Apr 06, 1984
BUTALBITAL, ASPIRIN AND CAFFEINEWATSON LABSANDA 086237—Mar 23, 1984
BUTALBITAL, ASPIRIN AND CAFFEINERLDHIKMA INTL PHARMSANDA 086162—Feb 16, 1984
BUTALBITAL, ASPIRIN AND CAFFEINEPURACAP PHARMANDA 087048—Dec 09, 1983
BUTALBITAL, ASPIRIN AND CAFFEINEACTAVIS ELIZABETHANDA 086710—Aug 23, 1983

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 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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