Application 206937

Type: ANDA
Sponsor: TORRENT

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206937-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2016-10-21
A206937-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		RS	2016-10-21

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206937-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2016-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206937-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RS	2016-10-21	`4b0b4de00fa7…`

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	A206937-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206937-002	AB1	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A206937-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206937-002	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206937-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206937-002	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206937-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206937-002	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206937-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206937-002	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206937-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206937-002	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206937-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206937-002	AB1	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 4 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a7bea6e9-cf90-a963-e053-2a95a90a1068	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	50345702-9869-5335-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	NorthStar Rx LLC	1f8b1834-d5d7-72b6-d2ed-cb074344d59e	2024-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	4915e22f-cecb-4261-8389-9bb417a20e82	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	80e52273-9741-6aef-eb24-8a93ead85ba7	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluoxetine hydrochloride generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	180a07fd-1f6a-4617-b8e0-f938c65ba273	2024-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Medsource Pharmaceuticals	1302fc08-d5fa-54b4-e063-6394a90a5275	2024-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	NorthStar Rx LLC	97960730-432e-4e94-bb4e-62a3157270a8	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d7a4db7f-cdac-2b36-e053-2995a90a8d64	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	578ca8f8-86eb-4247-a0b3-50c3837a982e	2024-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	08f3c11c-9ba0-4c53-bf31-264725e611ea	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	3fba8d68-0663-4053-93ee-7531246fd47d	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	224c8c17-0183-4cd7-ab9e-0062f3c624f0	2023-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOXETINE HYDROCHLORIDE
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

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-443	Fluoxetine	Fluoxetine	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-443	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current
13668-473	Fluoxetine	Fluoxetine	Torrent Pharmaceuticals Limited	ANDA	Current