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Generated: August 20, 2017

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. It is available from one supplier. There are three patents protecting this drug. 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. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 021235

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 021235

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021235

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROZAC WEEKLY
fluoxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL 021235 NDA Eli Lilly and Company 0002-3004 0002-3004-75 2 BLISTER PACK in 1 CARTON (0002-3004-75) > 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 90MG BASE
Approval Date:Feb 26, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Nov 29, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Nov 29, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:May 29, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION

Expired Orange Book 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;ORAL021235-001Feb 26, 2001► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Merck
Federal Trade Commission
Queensland Health
Boehringer Ingelheim
Argus Health
Harvard Business School
QuintilesIMS
Chinese Patent Office

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