Sodium Tetradecyl Sulfate
Sodium Tetradecyl Sulfate Injection, 3% 60 mg/2 mL (30 mg/mL) FOR INTRAVENOUS USE ONLY Rx only
Approved
Approval ID
997394e1-ec1f-4093-e053-2a95a90a0ea0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)
DUNS: 118707839
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Tetradecyl Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24201-201
Application NumberANDA209937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Tetradecyl Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (4)
BENZYL ALCOHOLInactive
Quantity: 0.02 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 9 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM TETRADECYL SULFATEActive
Quantity: 30 mg in 1 mL
Code: Q1SUG5KBD6
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT