Application 075465

Type: ANDA
Sponsor: MARKSANS PHARMA

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
A075465-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29
A075465-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29
A075465-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075465-001	AB1
A075465-002	AB1
A075465-003	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	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2001-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075465-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2002-01-29	`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	A075465-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075465-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075465-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075465-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075465-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075465-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075465-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075465-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075465-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075465-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075465-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075465-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075465-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075465-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075465-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075465-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075465-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075465-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075465-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075465-001	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	f2a48124-0790-51c2-e053-2a95a90aa1af	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075465 application number: ANDA075465
Fluoxetine	FLUOXETINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d7a4db7f-cdac-2b36-e053-2995a90a8d64	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075465 application number: ANDA075465 ndc (product): 49483-702 ndc (product): 49483-701 ndc (product): 49483-703
Fluoxetine	FLUOXETINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	8e822937-9431-446f-88c4-330a25d12439	2023-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075465 application number: ANDA075465 ndc (product): 25000-147 ndc (product): 25000-148 ndc (product): 25000-149

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25000-147	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-147	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-147	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-148	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-148	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-148	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-149	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-149	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-149	Fluoxetine	Fluoxetine Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
45865-451	Fluoxetine	Fluoxetine	Medsource Pharmaceuticals	ANDA	Current
49483-701	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-701	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-702	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-702	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-703	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-703	Fluoxetine	Fluoxetine Hydrochloride	TIME CAP LABORATORIES, INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44258	ORIG	2005-08-01
39486	ORIG	2004-06-04
30894	ORIG	2004-06-04
8679	ORIG	2004-06-04
42998	ORIG	2003-08-04