FDA.report

Application 090828

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL800MG;160MGNoNo
002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL400MG;80MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-092Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBlenheim Pharmacal, Inc.ANDACurrent
53808-0981Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimState of Florida DOH Central PharmacyANDACurrent
67046-714Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimContract Pharmacy Services-PAANDACurrent
68462-339Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGlenmark Generics Inc. USAANDACurrent
68462-340Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGlenmark Generics Inc. USAANDACurrent