Is there a generic for Estramustine phosphate sodium?

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

What is the reference-listed drug for Estramustine phosphate sodium?

EMCYT (NDA 018045, PHARMACIA AND UPJOHN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Estramustine phosphate sodium are approved?

Estramustine phosphate sodium is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Estramustine phosphate sodium

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

Reference-listed drug:EMCYT · NDA 018045

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
EMCYTRLD	PHARMACIA AND UPJOHN	NDA 018045	—	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.

Estramustine phosphate sodium — frequently asked questions

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

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