Application 078619

Type: ANDA
Sponsor: AUROBINDO PHARMA

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	RLD / RS	Approval date
A078619-001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1		2008-01-31
A078619-002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1		2008-01-31
A078619-003	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	RS	2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078619-001	AB1
A078619-002	AB1
A078619-003	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	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-002	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-003	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE / ORAL	AB	2008-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078619-001	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB1	2008-01-31	`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	A078619-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078619-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078619-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078619-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078619-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078619-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078619-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078619-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078619-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078619-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078619-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078619-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078619-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078619-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078619-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078619-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078619-001	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 2 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE	A-S Medication Solutions	2c8970ad-2266-4653-b7eb-4c79ba926d89	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	A-S Medication Solutions	096e9438-2bed-434b-aa56-a6d55471fef1	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	851c4cfb-e1f0-4087-b13d-c07c25fea37d	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	45454555-7402-41cb-a452-e6a76e04f387	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	da6b9b19-2ea1-9a39-e053-2995a90ad730	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	dfae4357-b6f9-9a30-e053-2995a90a2667	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Northwind Health Company, LLC	cb66a702-7670-4a73-98fb-0e63151a1ffb	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 51655-100
Fluoxetine	FLUOXETINE HYDROCHLORIDE	QPharma Inc	fc754dff-cecb-fc6b-e053-6394a90ab371	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Cardinal Health 107, LLC	06394c4b-99f4-4257-bf29-53c170c5a061	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	CouplerLLC	3e111be4-28f0-c290-e063-6294a90a447f	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	4abbd9d9-e9b1-463d-8f39-f3f50d80f58a	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	NorthStar Rx LLC	3e1e767b-66a5-4f38-8142-84d40d447f92	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Aurobindo Pharma Limited	d0f00a25-1aec-42fd-a301-d3710ae3e1f3	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Major Pharmaceuticals	76b264ce-2a13-4511-8e21-4ffad0a327f9	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
FLUOXETINE	FLUOXETINE HYDROCHLORIDE	DIRECT RX	9b8d8da5-8c06-0942-e053-2995a90aa2c9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	9a151528-2fe0-4059-b7b7-fcb4e80a51e3	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 50090-0749 ndc (product): 50090-0745
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	42c4c341-8282-4961-8581-8a0430162559	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 50090-2589 ndc (product): 50090-2793
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	2f302db0-1c88-44cf-8258-3c1c60afb5a4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1fd00b7f-df07-455f-e063-6394a90a1f10	2024-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	1226a67f-ec09-42f6-9d1b-9ddd862ea0a0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 50090-6065

NDC Listings For This Application#

NDC listings for this application page 1 of 4 · 252 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8183	Fluoxetine	Fluoxetine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-065	Fluoxetine	Fluoxetine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-180	Fluoxetine	Fluoxetine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-583	Fluoxetine	Fluoxetine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
16714-720	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-720	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-720	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-720	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-720	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-721	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-721	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-721	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-721	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-721	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-722	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-722	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-722	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-722	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-722	Fluoxetine	Fluoxetine Hydrochloride	NorthStar Rx LLC	ANDA	Current
21695-052	Fluoxetine	Fluoxetine Hydrochloride	Rebel Distributors Corp	ANDA	Current
21695-053	Fluoxetine	Fluoxetine Hydrochloride	Rebel Distributors Corp	ANDA	Current
33261-045	Fluoxetine	Fluoxetine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-728	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-728	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-728	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-728	Fluoxetine	Fluoxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-570	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-712	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-993	Fluoxetine	Fluoxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-368	Fluoxetine	Fluoxetine Hydrochloride	Medsource Pharmaceuticals	ANDA	Current
50090-0745	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0745	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0745	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0745	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0749	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0749	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2589	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2793	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6064	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6065	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6066	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6081	Fluoxetine	Fluoxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-333	Fluoxetine	Fluoxetine Hydrochloride	AvPAK	ANDA	Current
50268-334	Fluoxetine	Fluoxetine Hydrochloride	AvPAK	ANDA	Current
50268-335	Fluoxetine	Fluoxetine Hydrochloride	AvPAK	ANDA	Current
50268-335	Fluoxetine	Fluoxetine Hydrochloride	AvPAK	ANDA	Current
50436-0924	Fluoxetine	Fluoxetine Hydrochloride	Unit Dose Services	ANDA	Current
50436-1930	Fluoxetine	Fluoxetine Hydrochloride	Unit Dose Services	ANDA	Current
51138-093	Fluoxetine	Fluoxetine Hydrochloride	Med-Health Pharma, LLC	ANDA	Current
51138-094	Fluoxetine	Fluoxetine Hydrochloride	Med-Health Pharma, LLC	ANDA	Current
51138-095	Fluoxetine	Fluoxetine Hydrochloride	Med-Health Pharma, LLC	ANDA	Current
51655-100	fluoxetine hydrochloride	fluoxetine hydrochloride	Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23913	ORIG	2008-02-28