FDA.reportPublic FDA data

Application 076899

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL400MG;80MGNoNo
002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL800MG;160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0138Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimKAISER FOUNDATION HOSPITALSANDACurrent
0440-2406Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimLiberty Pharmaceuticals, Inc.ANDACurrent
0615-0170Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-2725Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMajor PharmaceuticalsANDACurrent
0904-2725Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMajor PharmaceuticalsANDACurrent
10544-525Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBlenheim Pharmacal, Inc.ANDACurrent
12634-177Sulfamethoxazole and Trimethoprim DSSulfamethoxazole and Trimethoprim DSApotheca Inc.ANDACurrent
21695-125Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRebel Distributors Corp.ANDACurrent
33261-148Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAidarex Pharmaceuticals LLCANDACurrent
33261-396Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAidarex Pharmaceuticals LLCANDACurrent
42291-758Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKARE, Inc.ANDACurrent
42291-758Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKARE, Inc.ANDACurrent
42291-758Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKAREANDACurrent
42291-758Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKAREANDACurrent
42291-759Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKARE, Inc.ANDACurrent
42291-759Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKARE, Inc.ANDACurrent
42291-759Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKAREANDACurrent
42291-759Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAvKAREANDACurrent
43063-024Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-024Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-024Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-024Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-616Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-616Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-616Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-616Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-475Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMedsource PharmaceuticalsANDACurrent
50090-0017Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication Solutions LLCANDACurrent
50090-0018Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication Solutions LLCANDACurrent
50090-4852Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50436-4693Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimUnit Dose ServicesANDACurrent
50436-4693Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimUnit Dose ServicesANDACurrent
51655-186Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimNorthwind PharmaceuticalsANDACurrent
52959-144Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimH.J. Harkins Company, Inc.ANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York, LLCANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-271Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York, LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53746-272Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmneal Pharmaceuticals of New York LLCANDACurrent
53808-0798Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimState of Florida DOH Central PharmacyANDACurrent
54348-625Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ANDACurrent
54348-625Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ANDACurrent
55154-4988Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
55154-4988Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
55154-7895Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
55154-7895Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal Health 107, LLCANDACurrent
55154-7895Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
55289-241Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-241Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-241Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-241Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-241Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-457Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-457Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-457Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-457Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-457Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPD-Rx Pharmaceuticals, Inc.ANDACurrent
58517-140SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMNew Horizon Rx Group, LLCANDACurrent
60687-531Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
60687-531Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
60687-531Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
60687-542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
60687-542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
60687-542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAmerican Health PackagingANDACurrent
63187-782Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimProficient Rx LPANDACurrent
63187-782Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimProficient Rx LPANDACurrent
63629-1765Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-1765Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-1765Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-7671Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-7671Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-7671Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-7941Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent