Application 090745

Type: ANDA
Sponsor: SUN PHARM

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	Approval date
A090745-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11
A090745-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	2013-12-11

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	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2013-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	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	A090745-001	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	A090745-002	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	A090745-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	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 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090745-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090745-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090745-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090745-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090745-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090745-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090745-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090745-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090745-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090745-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090745-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090745-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090745-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090745-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090745-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090745-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090745-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090745-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090745-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine	DULOXETINE	Sun Pharmaceutical Industries, Inc.	f16beb64-5878-486a-82ee-8e83e728f26c	2021-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090745 application number: ANDA090745 ndc (product): 47335-383 ndc (product): 47335-381 ndc (product): 47335-382

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-381	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-381	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-381	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-381	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-382	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-382	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-382	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-382	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-383	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-383	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-383	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-383	Duloxetine	Duloxetine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-2212	Duloxetine	Duloxetine	A-S Medication Solutions	ANDA	Current
61919-483	DULOXETINE	DULOXETINE	DIRECT RX	ANDA	Current
61919-483	DULOXETINE	DULOXETINE	DIRECT RX	ANDA	Current
61919-483	DULOXETINE	DULOXETINE	DIRECT RX	ANDA	Current
61919-636	DULOXETINE	DULOXETINE	DIRECT RX	ANDA	Current
63629-5174	Duloxetine	Duloxetine	Bryant Ranch Prepack	ANDA	Current
63629-5174	Duloxetine	Duloxetine	Bryant Ranch Prepack	ANDA	Current
63629-5202	Duloxetine	Duloxetine	Bryant Ranch Prepack	ANDA	Current
63629-5202	Duloxetine	Duloxetine	Bryant Ranch Prepack	ANDA	Current
70518-0491	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current
70518-0491	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current
70518-1137	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9290	ORIG	2013-12-13