FDA.reportPublic FDA data

Application 077612

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION;ORAL200MG/5ML;40MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4793Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.ANDACurrent
62559-550Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimANI Pharmaceuticals, Inc.ANDACurrent
62559-550Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimANI Pharmaceuticals, Inc.ANDACurrent
62559-550Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimANI Pharmaceuticals, Inc.ANDACurrent
62559-550Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimANI Pharmaceuticals, Inc.ANDACurrent
63629-1969Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimBryant Ranch PrepackANDACurrent
63629-1969Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimBryant Ranch PrepackANDACurrent
63629-1969Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimBryant Ranch PrepackANDACurrent
66993-727Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprimPrasco LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39536SUPPL2014-02-06