Sulfacetamide Sodium
SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%
Approved
Approval ID
92f53dc3-cedc-4963-911a-77c3431d4765
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-117
Application NumberANDA089560
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfacetamide Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 17, 2011
FDA Product Classification
INGREDIENTS (6)
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
METHYLCELLULOSE (4000 CPS)Inactive
Code: MRJ667KA5E
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT