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Last Updated: December 15, 2025

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. Sixty-seven 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

Medical Subject Heading (MeSH) Categories for 020101

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

Profile for product number 001

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Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Expired US Patents for NDA 020101

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,018,895	⤷ Get Started Free
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,626,549*PED	⤷ Get Started Free
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,314,081*PED	⤷ Get Started Free
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,194,009	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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