FDA.reportPublic FDA data

Application 203484

Type
ANDA
Sponsor
LARKEN LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLZITALACETAMINOPHEN; BUTALBITALTABLET;ORAL325MG;25MGNoYes
002BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL325MG;50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54879-026Butalbital And Acetaminophenbutalbital and acetaminophenSTI Pharma LLCANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-721Butalbital And Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722butalbital and acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722butalbital and acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722butalbital and acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722butalbital and acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722butalbital and acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-722Butalbital and Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752Allzitalbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-752ALLZITALbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
68047-753Butalbital and Acetaminophenbutalbital and acetaminophenLarken Laboratories, Inc.ANDACurrent
70362-722ALLZITALbutalbital and acetaminophenSkylar Laboratories, LLCANDACurrent
70362-722ALLZITALbutalbital and acetaminophenSkylar Laboratories, LLCANDACurrent
70569-150ALLZITALbutalbital and acetaminophenPhlight Pharma, LLCANDACurrent
70569-150ALLZITALbutalbital and acetaminophenPhlight Pharma, LLCANDACurrent
70569-150ALLZITALbutalbital and acetaminophenPhlight Pharma, LLCANDACurrent
70569-150ALLZITALbutalbital and acetaminophenPhlight Pharma, LLCANDACurrent
71993-301Butalbital and AcetaminophenButalbital and AcetaminophenAtland Pharmaceuticals, LLCANDACurrent
73159-003Butalbital and Acetaminophenbutalbital and acetaminophenLacer Pharma, LLCANDACurrent