ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, USP
Approved
Approval ID
60d1aea0-f106-4b20-8ef4-7a80e37f8a50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-690
Application NumberANDA062759
Product Classification
M
Marketing Category
C73584
G
Generic Name
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2007
FDA Product Classification
INGREDIENTS (8)
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
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT