Application 021235

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROZAC WEEKLY	FLUOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 90MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021235-001	PROZAC WEEKLY	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2001-02-26

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021235-001	PROZAC WEEKLY	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021235-001	PROZAC WEEKLY	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2001-02-26	`f41ea6bd6efb…`

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 4 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	3d5d03ff-0d0c-429f-b747-31ff3465d39d	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1fd00b7f-df07-455f-e063-6394a90a1f10	2024-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	1226a67f-ec09-42f6-9d1b-9ddd862ea0a0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b1409772-e719-67f5-e053-2995a90ab5b6	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a32f1a0b-a9ee-883a-e053-2a95a90a8c12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a7bea6e9-cf90-a963-e053-2a95a90a1068	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	50345702-9869-5335-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	NorthStar Rx LLC	1f8b1834-d5d7-72b6-d2ed-cb074344d59e	2024-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	4915e22f-cecb-4261-8389-9bb417a20e82	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	80e52273-9741-6aef-eb24-8a93ead85ba7	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	180a07fd-1f6a-4617-b8e0-f938c65ba273	2024-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Medsource Pharmaceuticals	1302fc08-d5fa-54b4-e063-6394a90a5275	2024-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NorthStar Rx LLC	97960730-432e-4e94-bb4e-62a3157270a8	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d7a4db7f-cdac-2b36-e053-2995a90a8d64	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	578ca8f8-86eb-4247-a0b3-50c3837a982e	2024-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	08f3c11c-9ba0-4c53-bf31-264725e611ea	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	BluePoint Laboratories	f89a5800-6fdb-4938-a28e-3bf1aeb1c21a	2023-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	3fba8d68-0663-4053-93ee-7531246fd47d	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a408c325-d2d5-4e88-85ce-96913eb58183	2023-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	224c8c17-0183-4cd7-ab9e-0062f3c624f0	2023-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-3004	Prozac	Fluoxetine hydrochloride	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47756	SUPPL	2017-03-29
47718	SUPPL	2017-03-27
47717	SUPPL	2017-03-27
46820	SUPPL	2017-01-13
46699	SUPPL	2017-01-06
27172	SUPPL	2015-08-06
14711	SUPPL	2015-08-06
4731	SUPPL	2014-07-24
14710	SUPPL	2014-07-23
21532	SUPPL	2013-10-23
27171	SUPPL	2013-07-30
14709	SUPPL	2013-07-30
27170	SUPPL	2013-01-07
14708	SUPPL	2013-01-07
14707	SUPPL	2013-01-07
4730	SUPPL	2013-01-07
4729	SUPPL	2011-06-23
14706	SUPPL	2011-06-16
27169	SUPPL	2011-04-13
27168	SUPPL	2011-04-13
4728	SUPPL	2011-04-13
14705	SUPPL	2011-04-04
14704	SUPPL	2011-04-04
14703	SUPPL	2011-04-04
14702	SUPPL	2009-02-04
4727	SUPPL	2009-02-03
27167	SUPPL	2008-03-24
14701	SUPPL	2008-03-24
14700	SUPPL	2008-03-13
27166	SUPPL	2008-03-12
27165	SUPPL	2007-08-07
14699	SUPPL	2007-08-03
27164	SUPPL	2007-03-23
14698	SUPPL	2006-09-21
4726	SUPPL	2006-04-13
27162	SUPPL	2005-12-06
44107	ORIG	2005-08-01
27163	SUPPL	2005-02-23
21531	ORIG	2004-10-18
4725	SUPPL	2004-08-25
36429	ORIG	2001-02-26
27161	ORIG	2001-02-26