Application 211051

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 60MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211051-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL			2018-12-03

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL		2018-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211051-001	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET / ORAL	AB	2018-12-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211051-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211051-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211051-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211051-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211051-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211051-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211051-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211051-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211051-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211051-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211051-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211051-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211051-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A211051-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211051-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211051-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211051-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211051-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211051-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211051-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211051-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211051-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211051-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211051-001	AB	1	`cb3db0bc1861…`

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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	4afdf87f-462b-4a38-9c0d-e74995c492ea	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	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	PD-Rx Pharmaceuticals, Inc.	a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9	2026-06-05	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.	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	2026-05-05	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
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d26f7450-7650-43df-a63b-1fe2472882a9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5020d0d6-969e-b4cd-e063-6294a90af9d2	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5262	Fluoxetine	Fluoxetine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5262	Fluoxetine	Fluoxetine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5262	Fluoxetine	Fluoxetine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5262	Fluoxetine	Fluoxetine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5262	Fluoxetine	Fluoxetine	Teva Pharmaceuticals USA, Inc.	ANDA	Current