SULFACETAMIDE SODIUM
Approved
Approval ID
9294ddc5-3778-40af-9d6c-1bea2e145220
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULFACETAMIDE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-209
Application NumberANDA089560
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULFACETAMIDE SODIUM
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 27, 2011
FDA Product Classification
INGREDIENTS (6)
METHYLCELLULOSE (100 CPS)Inactive
Code: 4GFU244C4J
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT