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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 208811

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NDA 208811 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Teva Pharms Usa Inc, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from nineteen suppliers. There are three patents protecting this drug. Additional details are available on the FULVESTRANT profile page.

The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.

Summary for 208811

Tradename:	FULVESTRANT
Applicant:	Eugia Pharma
Ingredient:	fulvestrant
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/5ML (50MG/ML)
Approval Date:	Jul 23, 2019	TE:	AO	RLD:	No

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