ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, USP
Approved
Approval ID
eb6ea746-3228-4969-8a26-653288662fd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0971
Application NumberANDA062759
Product Classification
M
Marketing Category
C73584
G
Generic Name
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2010
FDA Product Classification
INGREDIENTS (8)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 200 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIB
LACTOSE, ANHYDROUSInactive
Code: 3SY5LH9PMK
Classification: IACT
SULFISOXAZOLE ACETYLActive
Quantity: 600 mg in 5 mL
Code: WBT5QH3KED
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT