FDA.reportPublic FDA data

Application 074650

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-779SULFAMETHOXAZOLE and TRIMETHOPRIMSULFAMETHOXAZOLE and TRIMETHOPRIMApotheca, Inc.ANDACurrent
17856-0823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAtlantic Biologicals CorpsANDACurrent
17856-0823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAtlantic Biologicals CorpsANDACurrent
21695-701Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRebel Distributors CorpANDACurrent
50090-4584Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAkorn Operating Company LLCANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAkorn Operating Company LLCANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
52959-766Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimH.J. Harkins Company, Inc.ANDACurrent
68788-9102Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPreferred PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18360SUPPL2014-02-06
42857ORIG2012-04-13