Application 090778

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	No	No
002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 30MG BASE	No	No
003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG 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
A090778-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090778-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11
A090778-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090778-001	AB
A090778-002	AB
A090778-003	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	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090778-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`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	A090778-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090778-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090778-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090778-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090778-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090778-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090778-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090778-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090778-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090778-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090778-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090778-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090778-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090778-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090778-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090778-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090778-001	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine HCL DR	DULOXETINE HCL	Advanced Rx of Tennessee, LLC	afd59273-75cb-5f33-e053-2995a90ab25f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778
Duloxetine	DULOXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	3adfceb3-5f89-4bcf-b874-e3cb572a98b6	2024-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778 ndc (product): 59651-279 ndc (product): 59651-280 ndc (product): 59651-282
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	51c342c9-b9c6-467d-8fea-b73d72e3febc	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778 ndc (product): 63187-666
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	c34f6115-f447-450f-8c83-58f3c51a76c9	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778 ndc (product): 63187-612
Duloxetine	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b102b8e6-d58f-419c-bb35-720bafa13294	2020-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090778 application number: ANDA090778

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 123 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7043	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7043	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7044	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7044	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7044	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7045	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7045	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7045	Duloxetine	Duloxetine Hydrochloride	Major Pharmaceuticals	ANDA	Current
42292-020	Duloxetine	Duloxetine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
42292-021	Duloxetine	Duloxetine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-877	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-878	Duloxetine	Duloxetine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2585	Duloxetine	Duloxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2585	Duloxetine	Duloxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2844	Duloxetine	Duloxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2844	Duloxetine	Duloxetine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0018	Duloxetine Hydrochloride	Duloxetine Hydrochloride	Unit Dose Services	ANDA	Current
50436-0019	Duloxetine	Duloxetine Hydrochloride	Unit Dose Services	ANDA	Current
55154-2341	Duloxetine	Duloxetine Hydrochloride	Cardinal Health	ANDA	Current
55154-2342	Duloxetine	Duloxetine Hydrochloride	Cardinal Health	ANDA	Current
55700-079	Duloxetine	Duloxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-080	Duloxetine	Duloxetine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-017	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-018	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
57237-019	Duloxetine	Duloxetine Hydrochloride	Rising Health, LLC	ANDA	Current
59651-279	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-279	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-279	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-279	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-279	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-280	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-280	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-280	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-280	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-280	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-282	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-282	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-282	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-282	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
59651-282	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
63187-612	Duloxetine	Duloxetine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-612	Duloxetine	Duloxetine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-666	Duloxetine	Duloxetine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-666	Duloxetine	Duloxetine Hydrochloride	Proficient Rx LP	ANDA	Current
65862-451	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-451	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-452	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-452	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-453	Duloxetine	Duloxetine Hydrochloride	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9293	ORIG	2013-12-13