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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
Covington
Cantor Fitzgerald
Mallinckrodt
Medtronic
Novartis
Chubb
Julphar
Johnson and Johnson

Generated: February 23, 2018

DrugPatentWatch Database Preview

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. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FASLODEX profile page.

The generic ingredient in FASLODEX is fulvestrant. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 021344
Tradename:FASLODEX
Applicant:Astrazeneca
Ingredient:fulvestrant
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021344
Suppliers and Packaging for NDA: 021344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344 NDA AstraZeneca Pharmaceuticals LP 0310-0720 N 0310-0720-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength50MG/ML
Approval Date:Apr 25, 2002TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:MONOTHERAPY FOR THE TREATMENT OF HORMONE RECEPTOR (HR) POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
Regulatory Exclusivity Expiration:Feb 19, 2019
Regulatory Exclusivity Use:TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
Patent:➤ Sign UpPatent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?Y

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Deloitte
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US Department of Justice
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