Is there a generic for Sodium tetradecyl sulfate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Sodium tetradecyl sulfate, referencing the brand SOTRADECOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sodium tetradecyl sulfate?

SOTRADECOL (NDA 005970, ELKINS SINN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sodium tetradecyl sulfate are approved?

Sodium tetradecyl sulfate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Sodium tetradecyl sulfate

Sodium tetradecyl sulfate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SOTRADECOL · NDA 005970

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SOTRADECOLRLD×2	ELKINS SINN	NDA 005970	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
SODIUM TETRADECYL SULFATE	HIKMA	ANDA 209937	AP	Dec 09, 2019
SOTRADECOL×2	MYLAN INSTITUTIONAL	ANDA 040541	—	Nov 12, 2004

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Sodium tetradecyl sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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