Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021235

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NDA 021235 describes PROZAC WEEKLY, which is a drug marketed by Lilly and is included in one NDA. Additional details are available on the PROZAC WEEKLY profile page.

The generic ingredient in PROZAC WEEKLY is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 021235
Tradename:PROZAC WEEKLY
Applicant:Lilly
Ingredient:fluoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 021235
Tradename Dosage Ingredient NDA Submissiondate
PROZAC WEEKLY CAPSULE, DELAYED REL PELLETS;ORAL fluoxetine hydrochloride 021235

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 90MG BASE
Approval Date:Feb 26, 2001TE:RLD:Yes

Expired US Patents for NDA 021235

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001   Start Trial   Start Trial
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001   Start Trial   Start Trial
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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