Application 208698

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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
A208698-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2017-04-05
A208698-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2017-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208698-001	AB
A208698-002	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	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208698-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2017-04-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208698-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2017-04-05	`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	A208698-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208698-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208698-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208698-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208698-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208698-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208698-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208698-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208698-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208698-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208698-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208698-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208698-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208698-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208698-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208698-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208698-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208698-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208698-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208698-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208698-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208698-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208698-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208698-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208698-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208698-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208698-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208698-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208698-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208698-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208698-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208698-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208698-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208698-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208698-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208698-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208698-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208698-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208698-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208698-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	ada19ae4-f3bd-47fa-a5c3-a6bb3aa34943	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208698 application number: ANDA208698
Fluoxetine	FLUOXETINE	Alembic Pharmaceuticals Inc.	e9ee6e93-4a57-4fd1-a417-3944484dd32c	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208698 application number: ANDA208698 ndc (product): 62332-243 ndc (product): 62332-242
Fluoxetine Hydrochloride	FLUOXETINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9c5112c0-c721-4086-9a75-3b7f931430bb	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208698 application number: ANDA208698 ndc (product): 46708-243 ndc (product): 46708-242

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-242	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-242	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-243	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-243	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
55700-617	Fluoxetine	Fluoxetine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
62332-242	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-242	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-242	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-242	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-243	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-243	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-243	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-243	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current