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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 211689


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NDA 211689 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 twenty 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-one suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 211689
Tradename:FULVESTRANT
Applicant:Accord Hlthcare
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 211689
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 211689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 211689 ANDA Accord Healthcare Inc. 16729-436 16729-436-30 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 211689 ANDA BluePoint Laboratories 68001-522 68001-522-85 2 SYRINGE, GLASS in 1 CARTON (68001-522-85) / 5 mL in 1 SYRINGE, GLASS (68001-522-86)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Nov 17, 2020TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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