Application 213286

Type: ANDA
Sponsor: AUROBINDO PHARMA 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
A213286-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08
A213286-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2020-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213286-001	AB
A213286-002	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 2 · 74 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
2026-02-19 14:30 UTC	2026-02	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2020-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2020-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2020-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213286-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2020-04-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213286-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2020-04-08	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A213286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213286-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213286-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213286-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213286-002	AB	1	`87673890dc5c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	09fb3100-1e06-4cdc-8016-7e4f5d097490	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	c1c7ec04-dd9e-400f-8f49-e900945fc61c	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286
Fluoxetine	FLUOXETINE	Bryant Ranch Prepack	97e7929f-dec4-467d-93c2-93360884e9e9	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	ac1651cc-4a2e-47cf-8a7e-be7ddcaf9f31	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	58b39e6a-3aae-4551-b081-586a4506aef2	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	3daecd20-6a59-44d3-8269-4912214c08b4	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213286 application number: ANDA213286 ndc (product): 59651-309 ndc (product): 59651-308

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-308	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current
59651-308	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current
59651-308	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current
59651-309	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current
59651-309	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current
59651-309	Fluoxetine	Fluoxetine	Aurobindo Pharma Limited	ANDA	Current