Application 018936

Type: NDA
Sponsor: ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	Yes	No
003	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG BASE	Yes	Yes
004	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 60MG BASE	No	No
006	PROZAC	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	Yes	No
007	SARAFEM	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
008	SARAFEM	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018936-001	PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	RLD	1987-12-29
N018936-003	PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	RLD	1999-06-15
N018936-004	PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE / ORAL		1999-06-15
N018936-006	PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	RLD	1992-12-23
N018936-007	SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-07-06
N018936-008	SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2000-07-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-004	PROZAC	EQ 60MG BASE	CAPSULE / ORAL			1999-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-006	PROZAC	EQ 10MG BASE	CAPSULE / ORAL	AB1	RLD	1992-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-007	SARAFEM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-008	SARAFEM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2000-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018936-001	PROZAC	EQ 20MG BASE	CAPSULE / ORAL	AB1	RLD	1987-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018936-003	PROZAC	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD, RS	1999-06-15	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018936-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018936-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018936-006	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018936-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018936-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018936-006	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018936-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018936-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018936-006	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018936-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018936-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018936-006	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018936-006	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018936-006	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018936-006	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018936-006	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018936-006	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018936-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018936-006	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018936-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018936-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018936-006	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018936-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018936-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018936-006	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018936-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018936-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018936-006	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018936-001	AB1	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prozac	FLUOXETINE HYDROCHLORIDE	Dista Products Company	c88f33ed-6dfb-4c5e-bc01-d8e36dd97299	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018936 application number: NDA018936 ndc (product): 0777-3104 ndc (product): 0777-3105 ndc (product): 0777-3107

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0777-3104	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3104	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3104	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3104	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3104	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3105	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3105	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3105	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3105	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3105	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3107	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3107	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3107	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3107	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
0777-3107	Prozac	Fluoxetine hydrochloride	Dista Products Company	NDA	Current
70518-2101	Prozac	Fluoxetine hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78575	SUPPL	2024-05-29
78425	SUPPL	2024-05-08
75234	SUPPL	2023-08-22
75197	SUPPL	2023-08-22
75196	SUPPL	2023-08-22
68970	SUPPL	2021-10-13
68911	SUPPL	2021-10-07
62738	SUPPL	2020-04-29
62737	SUPPL	2020-04-29
62733	SUPPL	2020-04-29
47757	SUPPL	2017-03-29
47720	SUPPL	2017-03-27
47719	SUPPL	2017-03-27
46818	SUPPL	2017-01-13
46698	SUPPL	2017-01-06
16122	SUPPL	2015-11-25
20169	SUPPL	2015-11-18
40831	SUPPL	2015-11-05
16120	SUPPL	2014-10-15
11380	SUPPL	2014-10-15
16121	SUPPL	2014-07-24
33668	SUPPL	2014-07-23
20168	SUPPL	2013-10-21
33667	SUPPL	2013-07-30
16119	SUPPL	2013-07-30
11379	SUPPL	2013-07-30
1146	SUPPL	2013-07-30
33666	SUPPL	2013-01-07
33665	SUPPL	2013-01-07
16118	SUPPL	2013-01-07
1145	SUPPL	2013-01-07
33664	SUPPL	2011-06-16
16117	SUPPL	2011-06-16
16116	SUPPL	2011-04-13
1144	SUPPL	2011-04-13
1143	SUPPL	2011-04-13
33663	SUPPL	2011-04-04
33662	SUPPL	2011-04-04
11378	SUPPL	2011-04-04
33661	SUPPL	2009-06-24
16115	SUPPL	2009-06-24
16110	SUPPL	2009-03-24
1139	SUPPL	2009-03-24
33658	SUPPL	2009-03-20
11372	SUPPL	2009-03-20
11377	SUPPL	2009-02-04
16114	SUPPL	2009-02-03
16113	SUPPL	2008-07-01
11376	SUPPL	2008-06-30
11375	SUPPL	2008-03-24
1142	SUPPL	2008-03-24
33660	SUPPL	2008-03-13
16112	SUPPL	2008-03-12
40828	SUPPL	2007-12-06
16111	SUPPL	2007-08-07
1141	SUPPL	2007-08-07
11374	SUPPL	2007-08-03
11373	SUPPL	2007-08-03
1140	SUPPL	2007-03-23
20166	SUPPL	2007-02-20
20165	SUPPL	2007-02-20
20164	SUPPL	2007-02-20
33659	SUPPL	2006-09-21
16109	SUPPL	2006-04-13
16107	SUPPL	2005-12-05
1138	SUPPL	2005-12-05
23544	ORIG	2005-08-01
16108	SUPPL	2005-02-23
1137	SUPPL	2004-09-03
1136	SUPPL	2004-08-25
40830	SUPPL	2004-08-09
20163	SUPPL	2004-08-09
40829	SUPPL	2003-09-25
20167	SUPPL	2003-09-25
16105	SUPPL	2003-01-07
11371	SUPPL	2003-01-07
33656	SUPPL	2002-07-29
33657	SUPPL	2002-06-12
16106	SUPPL	2002-06-12
11370	SUPPL	2000-07-06
1135	SUPPL	2000-07-06