Details for New Drug Application (NDA): 215234

NDA 215234 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 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 215234

Tradename:	FULVESTRANT
Applicant:	Zydus Pharms
Ingredient:	fulvestrant
Patents:	0

Pharmacology for NDA: 215234

Mechanism of Action

Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 215234

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215234	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1688	70710-1688-8	2 SYRINGE, GLASS in 1 CARTON (70710-1688-8) / 5 mL in 1 SYRINGE, GLASS (70710-1688-2)
FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	215234	ANDA	Zydus Lifesciences Limited	70771-1626	70771-1626-8	2 SYRINGE, GLASS in 1 CARTON (70771-1626-8) / 5 mL in 1 SYRINGE, GLASS (70771-1626-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	250MG/5ML (50MG/ML)
Approval Date:	Jul 29, 2021	TE:	AO	RLD:	No

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