PROZAC / SARAFEM — FDA application NDA018936

Application NDA018936 · type NDA · FDA status: approved · original approval 1987-12-29

Listed sponsor: ELI LILLY AND CO · LLY company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 20MG BASE	Discontinued	not listed	Yes
003	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 40MG BASE	Discontinued	not listed	Yes
004	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 60MG BASE	Discontinued	not listed	No
006	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 10MG BASE	Discontinued	not listed	Yes
007	SARAFEM	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
008	SARAFEM	FLUOXETINE HYDROCHLORIDE	CAPSULE	ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

FLUOXETINE HYDROCHLORIDE · UNII I9W7N6B1KJ · lmmol compound GIYXAJPCNFJEHY-UHFFFAOYSA-N · CHEMBL1201082

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.