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FDA Orange Book · active-ingredient family

Acetaminophen; butalbital

Acetaminophen; butalbital is approved in 22 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

22

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (22)

ProductApplicantApplicationTEApproved
BUTALBITAL AND ACETAMINOPHENQUAGENANDA 214305AAFeb 01, 2024
BUTALBITAL AND ACETAMINOPHENQUAGENANDA 214291AAJan 18, 2024
BUTALBITAL AND ACETAMINOPHENNE RX PHARMAANDA 214955AAAug 16, 2022
BUTALBITAL AND ACETAMINOPHEN×3SENORES PHARMSANDA 214088AAApr 07, 2022
BUTALBITAL AND ACETAMINOPHENGRANULESANDA 213115AANov 22, 2019
BUTALBITAL AND ACETAMINOPHENDR REDDYS LABS SAANDA 207313AADec 27, 2017
BUTALBITAL AND ACETAMINOPHENALVOGENANDA 207635—Jun 05, 2017
BUTALBITAL AND ACETAMINOPHENANDA REPOSITORYANDA 207386AANov 15, 2016
ALLZITAL×2PHARMOBEDIENTANDA 203484AADec 04, 2015
BUTALBITAL AND ACETAMINOPHENALVOGENANDA 205120—Oct 30, 2015
BUTALBITAL AND ACETAMINOPHENLGM PHARMAANDA 090956AAAug 23, 2011
BUTAPAPMIKARTANDA 089987AAOct 26, 1992
BUTAPAPMIKARTANDA 089988—Oct 26, 1992
TENCONMALLINCKRODTANDA 089405—May 15, 1990
BUTALBITAL AND ACETAMINOPHENHALSEYANDA 089568—Oct 05, 1988
TRIAPRINDUNHALLANDA 089268—Jul 02, 1987
BANCAPFOREST PHARMSANDA 088889—Jan 16, 1986
SEDAPAPMAYRANDANDA 088944—Oct 17, 1985
BUCETMALLINCKRODTANDA 088991—Jun 28, 1985
PHRENILIN FORTEVALEANTANDA 088831—Jun 19, 1985
PHRENILINRLDVALEANTANDA 087811—Jun 19, 1985
BUTALBITAL AND ACETAMINOPHENRLDWATSON LABSANDA 087550—Oct 19, 1984

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 — frequently asked questions

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

Agent CTA Background

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