MedPath
FDA Approval

Sodium Tetradecyl Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
January 10, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Hikma Pharmaceuticals USA Inc.

118707839

Products1

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

Sodium Tetradecyl Sulfate

Product Details

NDC Product Code
24201-201
Application Number
ANDA209937
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
January 10, 2023
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.02 mL in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACTQuantity: 9 mg in 1 mL
Code: Q1SUG5KBD6Class: ACTIBQuantity: 30 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
© Copyright 2025. All Rights Reserved by MedPath