Application 074803

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	No	No
002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074803-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL			2001-08-02
A074803-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL			2002-01-30

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2001-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2001-08-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2001-08-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2001-08-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074803-001	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL		2001-08-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074803-002	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2002-01-30	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074803-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074803-002	AB1	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074803-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074803-002	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074803-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074803-002	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074803-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074803-002	AB1	1	`ea99ee380514…`

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	a08dadff-f209-48dc-b597-6f085be13640	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Major Pharmaceuticals	76b264ce-2a13-4511-8e21-4ffad0a327f9	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	23899405-007b-48d9-82a9-a530b8e90784	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	583c5021-2948-7db4-e063-6294a90ae7dc	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d4043133-38de-4faa-bb76-8fafa5913844	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a04a5bed-d051-4bb4-ae20-b09b10d5c181	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	American Health Packaging	7bee936b-0130-4a6b-a974-956aef5486d9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	77b6ae48-8e3a-42e6-9b5a-aeed750861e8	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUOXETINE HYDROCHLORIDE generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	fb0608d9-1ae3-43be-8a20-e9f34e955862	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d5a267cb-08bd-4530-a7a8-2bceddd828e5	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	72e391aa-1a46-4589-8550-f83ac9241cf1	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	32afb28a-dc4c-4a7e-9701-1825f805e7df	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	20516384-6517-48be-bd6e-718250878a76	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	887fc670-db67-4cfe-967b-46b38375dae5	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	023cef65-c9c2-4d70-af66-198fb1b57714	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5386a140-7c5b-5959-e063-6294a90a2ad0	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	992060ee-fb4e-4c6d-9ffe-30902bc63af2	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Par Health USA, LLC	53ac797d-8792-4a8c-9708-d1de3d377e8f	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	a9de93d4-2edc-2838-e053-2995a90a8ed6	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d7a196b-91de-4753-8bb6-c6d5c668952d	2026-04-29	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23755	ORIG	2005-08-01
30701	ORIG	2004-06-04
30700	ORIG	2004-06-04
18368	ORIG	2004-06-04
42880	ORIG	2003-08-04
30703	SUPPL	2003-04-09
30702	SUPPL	2003-04-09
8449	SUPPL	2003-04-09
8448	SUPPL	2003-04-09
8447	SUPPL	2003-04-09
8446	SUPPL	2003-04-09