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Silver Sulfadiazine

silver sulfadiazine 1% cream

Approved
Approval ID

f81457dc-2671-458f-8ed5-b45528e6aa17

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 2, 2012

Manufacturers
FDA

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

DUNS: 831276758

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Silver Sulfadiazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49999-185
Application NumberANDA018578
Product Classification
M
Marketing Category
C73584
G
Generic Name
Silver Sulfadiazine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 22, 2012
FDA Product Classification

INGREDIENTS (11)

SILVER SULFADIAZINEActive
Quantity: 10 g in 1000 g
Code: W46JY43EJR
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

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Silver Sulfadiazine - FDA Drug Approval Details