Last Updated: June 18, 2026

Details for New Drug Application (NDA): 215234


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NDA 215234 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in sixteen 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-two suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 215234
Tradename:FULVESTRANT
Applicant:Zydus Pharms
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 215234
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 215234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 215234 ANDA Zydus Pharmaceuticals USA Inc. 70710-1688 70710-1688-8 2 SYRINGE, GLASS in 1 CARTON (70710-1688-8) / 5 mL in 1 SYRINGE, GLASS (70710-1688-2)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 215234 ANDA Zydus Lifesciences Limited 70771-1626 70771-1626-8 2 SYRINGE, GLASS in 1 CARTON (70771-1626-8) / 5 mL in 1 SYRINGE, GLASS (70771-1626-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Jul 29, 2021TE:AORLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

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