FDA.report

Application 074951

Type
ANDA
Sponsor
STEVENS J

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1312Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateLannett Company, Inc.ANDACurrent
0527-1312Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateLannett Company, Inc.ANDACurrent
69238-1993Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateAmneal Pharmaceuticals LLCANDACurrent
69238-1993Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1993Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine PhosphateAmneal Pharmaceuticals NY LLCANDACurrent

Documents

DocumentSubmission typeDate
76079ORIG 2023-11-02
42905ORIG2003-08-04
8474ORIG1998-08-31