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FDA Orange Book · active-ingredient family

Acetaminophen; butalbital; caffeine

Acetaminophen; butalbital; caffeine is approved in 52 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

52

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (52)

ProductApplicantApplicationTEApproved
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGENANDA 216376AAMar 12, 2024
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGENANDA 214288AAFeb 08, 2024
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGENANDA 214287AAJan 18, 2024
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE×2HIKMAANDA 215135—Mar 25, 2022
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEINGENUS PHARMS LLCANDA 215047AANov 17, 2021
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE×2SENORES PHARMSANDA 214087AAAug 13, 2021
BUTALBITAL, ACETAMINOPHEN AND CAFFEINESTRIDES PHARMAANDA 203647—Sep 21, 2020
BUTALBITAL, ACETAMINOPHEN AND CAFFEINENESHER PHARMSANDA 211543—Jul 17, 2020
BUTALBITAL, ACETAMINOPHEN AND CAFFEINETAROANDA 213046AAJul 01, 2020
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRANULESANDA 213321AAApr 08, 2020
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDR REDDYS LABS SAANDA 210817AADec 17, 2019
BUTALBITAL, ACETAMINOPHEN AND CAFFEINELANNETT CO INCANDA 212082AADec 17, 2019
BUTALBITAL, ACETAMINOPHEN AND CAFFEINELANNETT CO INCANDA 212083AADec 17, 2019
BUTALBITAL, ACETAMINOPHEN AND CAFFEINELGM PHARMAANDA 209587AAOct 31, 2018
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEAUROLIFE PHARMA LLCANDA 204733AASep 26, 2018
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEABHAI LLCANDA 211106AASep 26, 2018
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEKEY THERAPANDA 206615—Aug 04, 2017
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEALVOGENANDA 204984—Jan 10, 2017
BUTALBITAL, ACETAMINOPHEN AND CAFFEINENUVO PHARMS INCANDA 207118AAOct 28, 2016
BUTALBITAL, ACETAMINOPHEN AND CAFFEINELANNETT CO INCANDA 200243AASep 13, 2012
BUTALBITAL, ACETAMINOPHEN AND CAFFEINELGM PHARMAANDA 040885AANov 16, 2009
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEMIRROR PHARMS LLCANDA 040883—Dec 23, 2008
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRANULESANDA 040864AADec 01, 2008
BUTALBITAL, ACETAMINOPHEN AND CAFFEINESUN PHARM INDUSTRIESANDA 040601—Jul 29, 2005
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEMIKARTANDA 040496—Dec 23, 2003
BUTALBITAL, ACETAMINOPHEN AND CAFFEINESTRIDES PHARMA INTLANDA 040511AAAug 27, 2003
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEVINTAGE PHARMSANDA 040513—Aug 25, 2003
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGENUSANDA 040387—Jan 31, 2003
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEABLEANDA 040390—Jul 23, 2001
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEABLEANDA 040394—Jul 23, 2001
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEHIKMAANDA 040336—Aug 18, 1999
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEHIKMAANDA 040261—Oct 28, 1998
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEWATSON LABSANDA 040267—Jul 30, 1998
ESGIC-PLUSMIKARTANDA 040085—Mar 28, 1996
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEHIKMA PHARMSANDA 089718—Jun 12, 1995
ESGICFOREST PHARMSANDA 089660—Dec 23, 1988
ESGIC-PLUSMIKARTANDA 089451—May 23, 1988
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEWATSON LABSANDA 089536—Feb 16, 1988
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEMIKARTANDA 089175AAJan 21, 1987
ANOQUANSHIREANDA 087628—Oct 01, 1986
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDR REDDYS LABS SAANDA 089007AAMar 17, 1986
MEDIGESIC PLUSUS CHEMANDA 089115—Jan 14, 1986
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DMANDA 088743—Jul 18, 1985
FEMCETMALLINCKRODTANDA 089102—Jun 19, 1985
TRIADMALLINCKRODTANDA 089023—Jun 19, 1985
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DMANDA 089067—Apr 19, 1985
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGRAHAM DMANDA 088765—Mar 27, 1985
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEMALLINCKRODTANDA 088758—Mar 27, 1985
BUTALBITAL, ACETAMINOPHEN AND CAFFEINESPECGX LLCANDA 087804—Jan 24, 1985
BUTALBITAL, ACETAMINOPHEN AND CAFFEINERLDGILBERT LABSANDA 088825—Dec 05, 1984
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGILBERT LABSANDA 087629—Nov 13, 1984
BUTALBITAL, ACETAMINOPHEN AND CAFFEINERLDACTAVIS LABS UT INCANDA 088616AANov 09, 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; caffeine — 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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