Is there a generic for Polyestradiol phosphate?

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

What is the reference-listed drug for Polyestradiol phosphate?

ESTRADURIN (NDA 010753, WYETH AYERST) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Polyestradiol phosphate are approved?

Polyestradiol phosphate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Polyestradiol phosphate

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

Reference-listed drug:ESTRADURIN · NDA 010753

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ESTRADURIN	WYETH AYERST	NDA 010753	—	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.

Polyestradiol phosphate — frequently asked questions

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

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