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Federal Trade Commission
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Julphar
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020974

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NDA 020974 describes PROZAC, which is a drug marketed by Eli Lilly And Co and Lilly and is included in four NDAs. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the PROZAC profile page.

The generic ingredient in PROZAC is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 020974

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 9, 1999TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 9, 1999TE:RLD:Yes

Expired Orange Book Patents for NDA: 020974

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LillyPROZACfluoxetine hydrochlorideTABLET;ORAL020974-001Mar 9, 1999► Subscribe► Subscribe
LillyPROZACfluoxetine hydrochlorideTABLET;ORAL020974-002Mar 9, 1999► Subscribe► Subscribe
LillyPROZACfluoxetine hydrochlorideTABLET;ORAL020974-002Mar 9, 1999► Subscribe► Subscribe
LillyPROZACfluoxetine hydrochlorideTABLET;ORAL020974-001Mar 9, 1999► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Julphar
McKesson
Daiichi Sankyo
US Army
AstraZeneca
Covington
Cipla
Deloitte
Merck
QuintilesIMS

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