FDA.reportPublic FDA data

Application 071017

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-940Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBlenheim Pharmacal, Inc.ANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1545Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1545Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-2873Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-2890Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
51655-187Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimNorthwind PharmaceuticalsANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53808-0914Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMState of Florida DOH Central PharmacyANDACurrent
55154-4390Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
61919-210SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMDIRECT RXANDACurrent
63629-6357Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6357Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6799Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6799Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63739-228Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMcKesson Corporation dba SKY PackagingANDACurrent
63739-228Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMcKesson CorporationANDACurrent
64725-0146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTYA PharmaceuticalsANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
70934-043Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-043Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76413-135Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCentral Texas Community Health CentersANDACurrent
76413-151Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCentral Texas Community Health CentersANDACurrent