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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215077


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NDA 215077 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 nineteen 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 suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 215077
Tradename:FULVESTRANT
Applicant:Alembic
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 215077
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 215077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 215077 ANDA Alembic Pharmaceuticals Inc. 62332-650 62332-650-10 2 SYRINGE in 1 CARTON (62332-650-10) / 5 mL in 1 SYRINGE (62332-650-05)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 215077 ANDA BluePoint Laboratories. 68001-626 68001-626-85 2 SYRINGE in 1 CARTON (68001-626-85) / 5 mL in 1 SYRINGE (68001-626-86)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Dec 22, 2022TE:AORLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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