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
24201-201Application Number
ANDA209937Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 10, 2023BENZYL 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