Application 203836

Type: ANDA
Sponsor: PAR FORM

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 1.

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
A203836-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2016-08-19
A203836-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2016-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203836-001	AB
A203836-002	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 3 · 82 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	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203836-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203836-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203836-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203836-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203836-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203836-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203836-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203836-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203836-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203836-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203836-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203836-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203836-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203836-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203836-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203836-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203836-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203836-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203836-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203836-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203836-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203836-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203836-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203836-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203836-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203836-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203836-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203836-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203836-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203836-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203836-002	AB	1	`782e0a99824c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d4043133-38de-4faa-bb76-8fafa5913844	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a04a5bed-d051-4bb4-ae20-b09b10d5c181	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	fb0608d9-1ae3-43be-8a20-e9f34e955862	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-2197
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	d5a267cb-08bd-4530-a7a8-2bceddd828e5	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-2198
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	72e391aa-1a46-4589-8550-f83ac9241cf1	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-2200
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Par Health USA, LLC	53ac797d-8792-4a8c-9708-d1de3d377e8f	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 49884-336 ndc (product): 49884-335
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	80816531-9db3-492b-aebc-4681bf3c1554	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-8989
fluoxetine hydrochloride	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	da785a8a-d897-494e-9fd2-1d09b32f0190	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203836 application number: ANDA203836 ndc (product): 63629-8990

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-335	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-335	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-335	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-336	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-336	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-336	fluoxetine hydrochloride	fluoxetine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
63629-2197	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2197	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2197	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2198	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2198	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2198	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2199	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2199	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2199	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2199	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2200	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2200	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2200	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8989	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8990	fluoxetine hydrochloride	fluoxetine hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-3083	fluoxetine hydrochloride	fluoxetine hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45200	ORIG	2016-08-19