Application 090223

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	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
A090223-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19
A090223-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19
A090223-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090223-001	AB1
A090223-002	AB1
A090223-003	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	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2009-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090223-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2009-03-19	`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	A090223-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090223-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090223-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090223-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090223-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090223-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090223-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090223-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090223-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090223-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090223-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090223-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090223-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090223-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090223-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090223-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090223-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090223-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090223-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090223-001	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	PD-Rx Pharmaceuticals, Inc.	620ecf00-5473-4420-afd1-94b5b38e7301	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090223 application number: ANDA090223 ndc (product): 43063-839
Fluoxetine	FLUOXETINE	Alembic Pharmaceuticals Inc.	9de65da4-73f8-4c88-8198-c92e63224ddb	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090223 application number: ANDA090223 ndc (product): 62332-022 ndc (product): 62332-024 ndc (product): 62332-023
Fluoxetine	FLUOXETINE	Alembic Pharmaceuticals Limited	6b9c2d73-866b-44c4-8718-e7e4a9a0fb55	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090223 application number: ANDA090223 ndc (product): 46708-273 ndc (product): 46708-272 ndc (product): 46708-271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-351	Fluoxetine	Fluoxetine	NorthStar RxLLC	ANDA	Current
16714-352	Fluoxetine	Fluoxetine	NorthStar RxLLC	ANDA	Current
16714-353	Fluoxetine	Fluoxetine	NorthStar RxLLC	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-839	Fluoxetine	Fluoxetine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
46708-271	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-271	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-272	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-272	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-273	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-273	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Limited	ANDA	Current
61919-253	FLUOXETINE	FLUOXETINE	DIRECT RX	ANDA	Current
61919-253	FLUOXETINE	FLUOXETINE	DIRECT RX	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-022	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-023	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-024	Fluoxetine	Fluoxetine	Alembic Pharmaceuticals Inc.	ANDA	Current
63739-493	Fluoxetine	Fluoxetine Capsules	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
63739-494	Fluoxetine	Fluoxetine Capsules	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
68001-129	Fluoxetine	Fluoxetine	BluePoint Laboratories	ANDA	Current
68001-129	Fluoxetine	Fluoxetine	BluePoint Laboratories	ANDA	Current
68071-3318	Fluoxetine	Fluoxetine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3367	Fluoxetine	Fluoxetine	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0565	Fluoxetine	Fluoxetine	Bryant Ranch Prepack	ANDA	Current
71335-0565	Fluoxetine	Fluoxetine	Bryant Ranch Prepack	ANDA	Current
71335-0565	Fluoxetine	Fluoxetine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44416	ORIG	2009-04-14