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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 205935


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NDA 205935 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 205935
Tradename:FULVESTRANT
Applicant:Sandoz
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 205935
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 205935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 205935 ANDA Sandoz Inc 0781-3532 0781-3532-12 2 SYRINGE, GLASS in 1 CARTON (0781-3532-12) / 5 mL in 1 SYRINGE, GLASS (0781-3532-01)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 205935 ANDA Sandoz Inc 0781-9055 0781-9055-12 2 SYRINGE, GLASS in 1 CARTON (0781-9055-12) / 5 mL in 1 SYRINGE, GLASS (0781-9055-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:May 14, 2019TE:AORLD:No

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Preferred Citation:

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