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Last Updated: December 30, 2025

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-seven 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

Medical Subject Heading (MeSH) Categories for 021235

Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 26, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021235

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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	5,910,319*PED	⤷ Get Started Free
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	5,985,322*PED	⤷ Get Started Free
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	RE39030	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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