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Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim Oral Suspension, USP

Approved
Approval ID

c9676c8a-4597-4dcf-8944-18ecc96004e2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 20, 2019

Manufacturers
FDA

Atlantic Biologicals Corps

DUNS: 047437707

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-0823
Application NumberANDA074650
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2019
FDA Product Classification

INGREDIENTS (15)

SULFAMETHOXAZOLEActive
Quantity: 200 mg in 5 mL
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 40 mg in 5 mL
Code: AN164J8Y0X
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT

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Sulfamethoxazole and Trimethoprim - FDA Drug Approval Details