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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 020974

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NDA 020974 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-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 020974

Tradename:	PROZAC
Applicant:	Lilly
Ingredient:	fluoxetine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020974

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 9, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 9, 1999	TE:		RLD:	Yes

Expired US 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;ORAL	020974-002	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-001	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-001	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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