Sulfamethoxazole and Trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM DS (DOUBLE STRENGTH) TABLETS, USP 800 mg/160 mg SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS, USP 400 mg/80 mg
Approved
Approval ID
897e4438-ba93-4d47-9d33-6ad1afcd7c25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULFAMETHOXAZOLE AND TRIMETHOPRIM
PRODUCT DETAILS
NDC Product Code53808-0914
Application NumberANDA071017
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 19, 2010
Generic NameSULFAMETHOXAZOLE AND TRIMETHOPRIM
INGREDIENTS (8)
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT