Last Updated: May 12, 2026

Details for New Drug Application (NDA): 215169

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NDA 215169 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Avyxa Holdings, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty 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-one suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.

Summary for 215169

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

Pharmacology for NDA: 215169

Mechanism of Action	Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 215169

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215169	ANDA	Eugia US LLC	55150-394	55150-394-02	2 SYRINGE in 1 CARTON (55150-394-02) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/5ML (50MG/ML)
Approval Date:	Jun 30, 2023	TE:		RLD:	No

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