Application 075755

Type: ANDA
Sponsor: MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075755-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02
A075755-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2001-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL			2001-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075755-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2001-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075755-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2001-08-02	`74a2ff9319b5…`

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	A075755-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075755-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075755-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075755-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075755-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075755-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075755-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075755-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075755-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075755-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075755-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075755-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075755-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075755-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075755-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075755-002	AB	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 5 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	be2e4325-feb9-4957-99c0-0a741a2d71a0	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	c4eeae3d-ae56-4e7e-b07d-02851f12039f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	8e822937-9431-446f-88c4-330a25d12439	2023-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	9f069b9b-16e4-4f0e-b420-4aa02ffbb632	2023-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Lannett Company, Inc.	c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1	2023-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	a5d49dee-a7de-44d8-80b5-1aeb89e76938	2023-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	dd659085-c32d-4d35-9d4b-bafa2a93f1fb	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine Hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	06582152-d7d3-4e87-8c13-a4416a6ec927	2023-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3453755b-3ed6-47a3-b4c7-c64758e7784c	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9c5112c0-c721-4086-9a75-3b7f931430bb	2023-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine Hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	70e115cc-6e9b-4b96-a1a9-779ed51ad0a7	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	ef699ed0-fd9e-4580-93bb-6fd50499dbd1	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	57f21f2b-0ec2-49dc-911a-806e5ae880c2	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	a6457d6e-5586-40e9-883d-352ee0527d80	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Proficient Rx LP	0cba1992-3990-42a1-9d9a-77b593bbb02e	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	02283de9-6087-45f7-a9ce-3b082ce860de	2019-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Vensun Pharmaceuticals, Inc.	b4f37ef1-8f5e-4318-90f1-2d8f8afb669c	2017-09-18	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0734	Fluoxetine	fluoxetine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0735	Fluoxetine	fluoxetine	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-5501	Fluoxetine Hydrochloride	Fluoxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-5502	Fluoxetine Hydrochloride	Fluoxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
21695-320	Fluoxetine Hydrochloride	fluoxetine hydrochloride	Rebel Distributors Corp	ANDA	Current
21695-321	Fluoxetine Hydrochloride	fluoxetine hydrochloride	Rebel Distributors Corp	ANDA	Current
63629-6790	Fluoxetine	fluoxetine	Bryant Ranch Prepack	ANDA	Current
63629-6790	Fluoxetine	fluoxetine	Bryant Ranch Prepack	ANDA	Current
70518-0971	Fluoxetine	fluoxetine	REMEDYREPACK INC.	ANDA	Current
70518-0971	Fluoxetine	fluoxetine	REMEDYREPACK INC.	ANDA	Current
70518-1757	Fluoxetine	fluoxetine	REMEDYREPACK INC.	ANDA	Current
70518-2162	Fluoxetine	fluoxetine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18424	SUPPL	2015-08-31
23773	ORIG	2005-08-01
18423	ORIG	2004-06-04
43023	ORIG	2003-08-04
31008	ORIG	2001-08-02