FDA.reportPublic FDA data

Application 207313

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALCAPSULE;ORAL300MG;50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-544butalbital and acetaminophenbutalbital and acetaminophenMayne PharmaANDACurrent
51862-544butalbital and acetaminophenbutalbital and acetaminophenMayne PharmaANDACurrent
51862-544butalbital and acetaminophenbutalbital and acetaminophenMayne PharmaANDACurrent
69499-342Butalbital and Acetaminophenbutalbital and acetaminophenSolubiomixANDACurrent
69499-342Butalbital and Acetaminophenbutalbital and acetaminophenSolubiomixANDACurrent
69499-342Butalbital and Acetaminophenbutalbital and acetaminophenSolubiomixANDACurrent