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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 209714

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NDA 209714 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 Inc, 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 209714

Tradename:	FULVESTRANT
Applicant:	Hbt Labs Inc
Ingredient:	fulvestrant
Patents:	0

Pharmacology for NDA: 209714

Mechanism of Action	Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 209714

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	209714	ANDA	Meitheal Pharmaceuticals Inc	71288-555	71288-555-86	2 SYRINGE in 1 CARTON (71288-555-86) / 5 mL in 1 SYRINGE (71288-555-85)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/5ML (50MG/ML)
Approval Date:	Nov 21, 2019	TE:	AO	RLD:	No

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