Last Updated: November 13, 2026

Details for New Drug Application (NDA): 083488

NDA 083488 describes ESTROGENIC SUBSTANCE, which is a drug marketed by Wyeth Ayerst and is included in one NDA. Additional details are available on the ESTROGENIC SUBSTANCE profile page.

The generic ingredient in ESTROGENIC SUBSTANCE is estrone. There is one drug master file entry for this compound. Additional details are available on the estrone profile page.

Summary for 083488

Tradename:	ESTROGENIC SUBSTANCE
Applicant:	Wyeth Ayerst
Ingredient:	estrone
Patents:	0

Medical Subject Heading (MeSH) Categories for 083488

Estrogens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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