Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution
Approved
Approval ID
e5a2f3a5-2b9d-4d02-ad5c-e6a890569363
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 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.
sulfacetamide sodium and prednisolone sodium phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-186
Application NumberANDA074449
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulfacetamide sodium and prednisolone sodium phosphate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 28, 2008
FDA Product Classification
INGREDIENTS (9)
sulfacetamide sodiumActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
thimerosalInactive
Code: 2225PI3MOV
Classification: IACT
prednisolone sodium phosphateActive
Quantity: 2.5 mg in 1 mL
Code: IV021NXA9J
Classification: ACTIB
boric acidInactive
Code: R57ZHV85D4
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT