FDA.reportPublic FDA data

Application 212231

Type
ANDA
Sponsor
SOMERSET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMINJECTABLE;INJECTION80MG/ML;16MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70069-361Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-361Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-361Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-361Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-362Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-362Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-362Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-362Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-363Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-363Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-363Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent
70069-363Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSomerset Therapeutics, LLCANDACurrent