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 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204597-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2015-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2015-03-16	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A204597-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204597-002	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204597-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204597-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204597-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204597-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204597-003	AB	1	`caaa826d4ba7…`
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…`

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 3 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	02283de9-6087-45f7-a9ce-3b082ce860de	2019-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597 ndc (product): 71335-0827 ndc (product): 71335-0923 ndc (product): 71335-1033
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Vensun Pharmaceuticals, Inc.	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	2017-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204597 application number: ANDA204597

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 2 of 2 · 131 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69367-236	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-236	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-237	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-237	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-237	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-237	Fluoxetine	Fluoxetine Hydrochloride	Westminster Pharmaceuticals, LLC	ANDA	Current
70518-0032	FLUOXETINE	FLUOXETINE	REMEDYREPACK INC.	ANDA	Current
70518-0262	FLUOXETINE	FLUOXETINE	REMEDYREPACK INC.	ANDA	Current
70518-0997	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0997	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0997	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1321	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1321	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2754	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2754	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2754	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2754	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2754	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3322	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3483	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3483	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3554	Fluoxetine	Fluoxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-077	Fluoxetine	Fluoxetine Hydrochloride	Denton Pharma, Inc.	ANDA	Current
70934-077	Fluoxetine	Fluoxetine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-077	Fluoxetine	Fluoxetine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-611	Fluoxetine	Fluoxetine Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-125	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-125	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-974	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-974	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-974	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-975	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-975	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-975	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-979	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-979	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-979	Fluoxetine	Fluoxetine Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0827	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0923	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1033	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1482	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1482	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1482	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1548	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1548	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1588	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2020	Fluoxetine	Fluoxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-683	Fluoxetine	Fluoxetine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
77771-113	Fluoxetine	Fluoxetine Hydrochloride	RADHA PHARMACEUTICALS, INC.	ANDA	Current
77771-114	Fluoxetine	Fluoxetine Hydrochloride	RADHA PHARMACEUTICALS, INC.	ANDA	Current
77771-115	Fluoxetine	Fluoxetine Hydrochloride	RADHA PHARMACEUTICALS, INC.	ANDA	Current