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Last Updated: June 16, 2021

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Details for New Drug Application (NDA): 020815


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NDA 020815 describes EVISTA, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the EVISTA profile page.

The generic ingredient in EVISTA is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.
Summary for 020815
Tradename:EVISTA
Applicant:Lilly
Ingredient:raloxifene hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020815
Suppliers and Packaging for NDA: 020815
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVISTA raloxifene hydrochloride TABLET;ORAL 020815 NDA Eli Lilly and Company 0002-4184 0002-4184-02 100 TABLET in 1 BOTTLE (0002-4184-02)
EVISTA raloxifene hydrochloride TABLET;ORAL 020815 NDA Eli Lilly and Company 0002-4184 0002-4184-30 30 TABLET in 1 BOTTLE (0002-4184-30)
Paragraph IV (Patent) Challenges for 020815
Tradename Dosage Ingredient NDA Submissiondate
EVISTA TABLET;ORAL raloxifene hydrochloride 020815

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Dec 9, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020815

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
AstraZeneca
Colorcon
Baxter
Express Scripts

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