Application 204597

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	No	No
003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204597-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16
A204597-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204597-001	AB1
A204597-002	AB1
A204597-003	AB

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 4 · 123 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	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A204597-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204597-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204597-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204597-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204597-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204597-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204597-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204597-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204597-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204597-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204597-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204597-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204597-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204597-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204597-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204597-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204597-001	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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	583c5021-2948-7db4-e063-6294a90ae7dc	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	023cef65-c9c2-4d70-af66-198fb1b57714	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine HCL	FLUOXETINE HCL	Direct_rx	48705e4f-c3ee-af78-e063-6394a90ad052	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5386a140-7c5b-5959-e063-6294a90a2ad0	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	a9de93d4-2edc-2838-e053-2995a90a8ed6	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 60760-311
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d26f7450-7650-43df-a63b-1fe2472882a9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Coupler LLC	5020d0d6-969e-b4cd-e063-6294a90af9d2	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ef0fa849-a3a0-45d2-9258-da2d46bee089	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 68788-7817
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ec608267-9c00-4d5c-a9ed-d89503f93d28	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 68788-7741
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	e83e2220-d32a-472c-bd9f-b87d0cf8858f	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 68788-7909
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	d121146e-7439-4169-a421-dab7b882b8aa	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	8b8fe00e-7a2f-486b-9b72-465a494d8939	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	1a07ebe9-3661-4a48-b8af-9b228875166a	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	77d5c10a-0cfc-4b89-942c-0fb5c67ae409	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	2c56a437-f6bf-4ac8-b1d9-fc8a605a97e7	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 50090-5678
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d23	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	aae4e339-5244-f6f9-e053-2995a90a42ce	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 51655-274
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1eec9d-f755-81a2-e053-2a95a90acb3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 51655-314
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	cdf3b608-e14c-474b-b80e-01ac5f701866	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	cca9edf9-2454-4bf9-98e8-c531a8f5dc42	2025-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 131 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-903	FLUOXETINE	FLUOXETINE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-904	FLUOXETINE	FLUOXETINE	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-905	FLUOXETINE	FLUOXETINE	Camber Pharmaceuticals, Inc.	ANDA	Current
42543-725	Fluoxetine	Fluoxetine Hydrochloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-726	Fluoxetine	Fluoxetine Hydrochloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-727	Fluoxetine	Fluoxetine Hydrochloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
45865-359	Fluoxetine	Fluoxetine Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
50090-2568	FLUOXETINE	FLUOXETINE	A-S Medication Solutions	ANDA	Current
50090-5678	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5678	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6193	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50228-113	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-113	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-113	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-113	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-113	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-114	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-114	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-114	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-114	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-114	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-115	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-115	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-115	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-115	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-115	Fluoxetine	Fluoxetine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50436-0726	Fluoxetine	Fluoxetine Hydrochloride	Unit Dose Services	ANDA	Current
51655-274	Fluoxetine	Fluoxetine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-274	Fluoxetine	Fluoxetine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-314	Fluoxetine	Fluoxetine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-314	Fluoxetine	Fluoxetine Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
53002-1671	Fluoxetine	Fluoxetine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1671	Fluoxetine	Fluoxetine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-593	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-609	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-609	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-654	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-866	Fluoxetine	Fluoxetine Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-866	Fluoxetine	Fluoxetine Hydrochloride	Quality Care Products, LLC	ANDA	Current
60760-311	Fluoxetine	Fluoxetine Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-745	FLUOXETINE	FLUOXETINE	Direct_Rx	ANDA	Current
63187-361	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-361	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
66267-587	FLUOXETINE	FLUOXETINE	NuCarePharmaceuticals, Inc.	ANDA	Current
66267-587	FLUOXETINE	FLUOXETINE	NuCarePharmaceuticals, Inc.	ANDA	Current
67046-214	FLUOXETINE	FLUOXETINE	Contract Pharmacy Services-PA	ANDA	Current
67296-1568	Fluoxetine	Fluoxetine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1568	Fluoxetine	Fluoxetine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1568	Fluoxetine	Fluoxetine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-2275	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2275	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2375	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3110	FLUOXETINE	FLUOXETINE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3130	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4314	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4314	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4653	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5240	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5240	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5240	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5276	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5276	Fluoxetine	Fluoxetine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6790	FLUOXETINE	FLUOXETINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6790	FLUOXETINE	FLUOXETINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6794	FLUOXETINE	FLUOXETINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6794	FLUOXETINE	FLUOXETINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7409	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7409	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7741	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7817	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7817	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7817	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7909	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7909	Fluoxetine	Fluoxetine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
69367-235	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-235	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-235	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-235	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-236	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-236	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current