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 1 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoxetine	FLUOXETINE HYDROCHLORIDE	American Health Packaging	7bee936b-0130-4a6b-a974-956aef5486d9	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	American Health Packaging	9965a672-7842-4926-9063-b76317c74862	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	32afb28a-dc4c-4a7e-9701-1825f805e7df	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	20516384-6517-48be-bd6e-718250878a76	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Unit Dose Solutions, Inc.	54d9f02c-95ea-99b1-e063-6294a90a9140	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	QPharma Inc	50253c6e-de36-05e6-e063-6294a90ad7a8	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 43063-993
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	992060ee-fb4e-4c6d-9ffe-30902bc63af2	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	PD-Rx Pharmaceuticals, Inc.	5dc20c8f-0d8f-400c-b850-fe1b7e3e75e3	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b7b102f0-17a2-49f7-b898-cb2e0fc71b4d	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 43063-712
Fluoxetine	FLUOXETINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d7a196b-91de-4753-8bb6-c6d5c668952d	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619 ndc (product): 43063-570
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	b8666383-462d-4a21-8f49-1d572da386d1	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	REMEDYREPACK INC.	d1c768b5-64bb-4036-aa92-797b3a5f92eb	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	Northwind Health Company, LLC	50369762-c7c3-d58e-e063-6294a90af8df	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	A-S Medication Solutions	679e439a-d955-4b54-8236-a2ccd9a2a10a	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	A-S Medication Solutions	3ce2f189-4386-4d0d-84f6-6d913ad1c09b	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	faf4bc0c-bf65-4a65-8f08-3d800185d6a8	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE	BluePoint Laboratories	daf33244-1348-4c34-b44c-9e35d5c48a3e	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	3ccada47-7eb9-285d-5059-06afb4466114	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	bb06af33-8ff7-0b02-0029-d628f62e1382	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078619 application number: ANDA078619

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