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Last Updated: November 4, 2024

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
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:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Apr 25, 2002TE:AORLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAMUSCULARStrength125MG/2.5ML (50MG/ML)
Approval Date:Apr 25, 2002TE:RLD:Yes

Expired US Patents for NDA 021344

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

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