Details for New Drug Application (NDA): 213553

NDA 213553 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 213553

Tradename:	FULVESTRANT
Applicant:	Xiromed
Ingredient:	fulvestrant
Patents:	0

Pharmacology for NDA: 213553

Mechanism of Action

Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 213553

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	213553	ANDA	Northstar Rx, LLC,	16714-070	16714-070-02	2 SYRINGE, GLASS in 1 CARTON (16714-070-02) / 5 mL in 1 SYRINGE, GLASS (16714-070-01)
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	213553	ANDA	Xiromed, LLC	70700-284	70700-284-98	2 SYRINGE, GLASS in 1 CARTON (70700-284-98) / 5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/5ML (50MG/ML)
Approval Date:	Aug 13, 2021	TE:	AO	RLD:	No

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