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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020101


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NDA 020101 describes PROZAC, which is a drug marketed by Eli Lilly And Co and Lilly and is included in four NDAs. It is available from one supplier. 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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 020101
Tradename:PROZAC
Applicant:Lilly
Ingredient:fluoxetine hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 24, 1991TE:RLD:Yes

Expired US Patents for NDA 020101

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991 ⤷  Sign Up ⤷  Sign Up
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991 ⤷  Sign Up ⤷  Sign Up
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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