FDA.reportPublic FDA data

Application 019429

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003FIORINAL W/CODEINEASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL325MG;50MG;40MG;30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6010Fiorinal with CodeineButalbital, Aspirin, Caffeine, and Codeine PhosphateAllergan, Inc.NDACurrent
0023-6010Fiorinal with CodeineButalbital, Aspirin, Caffeine, and Codeine PhosphateAllergan, Inc.NDACurrent
0023-6010Fiorinal with CodeineButalbital, Aspirin, Caffeine, and Codeine PhosphateAllergan, Inc.NDACurrent
0023-6010Fiorinal with CodeineButalbital, Aspirin, Caffeine, and Codeine PhosphateAllergan, Inc.NDACurrent
0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-956Fiorinal with CodeineButalbital, Aspirin, Caffeine, and Codeine PhosphateActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76226ORIG 2023-11-03
67325SUPPL2021-05-03
67324SUPPL2021-05-03
67323SUPPL2021-05-03
67251SUPPL2021-04-29
67250SUPPL2021-04-29
60340SUPPL2019-10-08
60310SUPPL2019-10-08
60309SUPPL2019-10-08
55831SUPPL2018-10-05
55830SUPPL2018-10-05
55647SUPPL2018-09-28
55646SUPPL2018-09-28
49629SUPPL2017-08-30
49589SUPPL2017-08-30
46396SUPPL2016-12-21
46233SUPPL2016-12-20
33742SUPPL2013-05-14
17393SUPPL2013-05-13
44441SUPPL2008-04-28
17392SUPPL2008-04-28
11503SUPPL2008-04-28
17391SUPPL2002-08-26