FDA.reportPublic FDA data

Application 018615

Type
NDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFATRIM PEDIATRICSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION;ORAL200MG/5ML;40MG/5MLNoNo
002SULFATRIMSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION;ORAL200MG/5ML;40MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0853Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0853Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0853Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0854SULFATRIMSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0854SULFATRIMSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0854SULFATRIMSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
0121-0854SULFATRIMSulfamethoxazole and TrimethoprimPharmaceutical Associates, Inc.NDACurrent
17856-0007SULFATRIMSulfamethoxazole and TrimethoprimAtlantic Biologicals CorpsNDACurrent
54879-007SULFATRIMSulfamethoxazole and TrimethoprimSTI Pharma LLCNDACurrent
67296-1163SULFATRIMSULFATRIMRedPharm Drug, Inc.NDACurrent
67296-1163SULFATRIMSULFATRIMRedPharm Drug, Inc.NDACurrent
67296-1657SULFATRIMSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.NDACurrent
67296-1657SULFATRIMSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.NDACurrent
68788-7083SULFATRIMSulfamethoxazole and TrimethoprimPreferred Pharmaceuticals Inc.NDACurrent
68788-7083SULFATRIMSulfamethoxazole and TrimethoprimPreferred PharmaceuticalsNDACurrent
68788-7345SULFATRIMSulfamethoxazole and TrimethoprimPreferred Pharmaceuticals, Inc.NDACurrent
68788-7345SULFATRIMSulfamethoxazole and TrimethoprimPreferred Pharmaceuticals, Inc.NDACurrent
68788-7345SULFATRIMSulfamethoxazole and TrimethoprimPreferred Pharmaceuticals, Inc.NDACurrent
68788-7345SULFATRIMSulfamethoxazole and TrimethoprimPreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81353SUPPL 2025-02-25
81328SUPPL 2025-02-24
78894SUPPL 2024-06-25
78890SUPPL 2024-06-25
69020SUPPL2021-10-19
69012SUPPL2021-10-18