FDA.reportPublic FDA data

Application 203335

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE;ORAL325MG;50MG;40MG;30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68308-312Butalbital, Aspirin, Caffeine, and Codeine PhosphateButalbital, Aspirin, Caffeine, and Codeine PhosphateMayne Pharma Inc.ANDACurrent
68308-312Butalbital, Aspirin, Caffeine, and Codeine PhosphateButalbital, Aspirin, Caffeine, and Codeine PhosphateMayne Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76112ORIG 2023-11-02
10197ORIG2015-11-04