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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 210044


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NDA 210044 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 210044
Tradename:FULVESTRANT
Applicant:Amneal
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 210044
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 210044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210044 ANDA BluePoint Laboratories 68001-484 68001-484-85 2 SYRINGE, GLASS in 1 CARTON (68001-484-85) / 5 mL in 1 SYRINGE, GLASS (68001-484-86)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210044 ANDA Amneal Pharmaceuticals LLC 70121-1463 70121-1463-9 2 SYRINGE, GLASS in 1 CARTON (70121-1463-9) / 5 mL in 1 SYRINGE, GLASS (70121-1463-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Mar 4, 2019TE:AORLD:No

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Preferred Citation:

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