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Details for New Drug Application (NDA): 020974

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NDA 020974 describes PROZAC, which is a drug marketed by Lilly and Eli Lilly And Co 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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 020974

Tradename:
PROZAC
Applicant:
Lilly
Ingredient:
fluoxetine hydrochloride
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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 9, 1999TE:RLD:No

Expired Orange Book Patents for NDA: 020974

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-001Mar 9, 19994,314,081*PED► subscribe
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-002Mar 9, 19994,626,549*PED► subscribe
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-002Mar 9, 19994,314,081*PED► subscribe
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