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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 018936

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NDA 018936 describes SARAFEM, which is a drug marketed by Eli Lilly And Co and Apil and is included in two NDAs. It is available from one supplier. Additional details are available on the SARAFEM profile page.

The generic ingredient in SARAFEM 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 018936

Tradename:	SARAFEM
Applicant:	Eli Lilly And Co
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 018936

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 018936

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

Suppliers and Packaging for NDA: 018936

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3104	0777-3104-02	100 CAPSULE in 1 BOTTLE (0777-3104-02)
SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3104	0777-3104-02	100 CAPSULE in 1 BOTTLE (0777-3104-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 29, 1987	TE:	AB1	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jun 15, 1999	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 60MG BASE
Approval Date:	Jun 15, 1999	TE:		RLD:	No

Expired US Patents for NDA 018936

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-003	Jun 15, 1999	4,626,549*PED	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	6,960,577	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,035,511	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-004	Jun 15, 1999	4,314,081*PED	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,647,591	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,590,213	⤷ Get Started Free
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	4,018,895	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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