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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021344

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NDA 021344 describes FASLODEX, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the FASLODEX profile page.

The generic ingredient in FASLODEX 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 021344

Tradename:	FASLODEX
Applicant:	Astrazeneca
Ingredient:	fulvestrant
Patents:	0

Pharmacology for NDA: 021344

Mechanism of Action	Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 021344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344	NDA	AstraZeneca Pharmaceuticals LP	0310-0720	0310-0720-10	2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 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:	Apr 25, 2002	TE:	AO	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	125MG/2.5ML (50MG/ML)
Approval Date:	Apr 25, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021344

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	FASLODEX	fulvestrant	SOLUTION;INTRAMUSCULAR	021344-001	Apr 25, 2002	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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