Is there a generic for Saralasin acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Saralasin acetate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Saralasin acetate?

SARENIN (NDA 018009, PROCTER AND GAMBLE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Saralasin acetate are approved?

Saralasin acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Saralasin acetate

Saralasin acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SARENIN · NDA 018009

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SARENIN	PROCTER AND GAMBLE	NDA 018009	—	Approved Prior to Jan 1, 1982

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.

Saralasin acetate — frequently asked questions

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

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