Application 211310

Type: ANDA
Sponsor: CSPC OUYI

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 43.

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
A211310-001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16
A211310-002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16
A211310-003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211310-001	AB
A211310-002	AB
A211310-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-002	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-003	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211310-001	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2018-10-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211310-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211310-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211310-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211310-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211310-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211310-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211310-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211310-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211310-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211310-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211310-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211310-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211310-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211310-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211310-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211310-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211310-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211310-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211310-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211310-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211310-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211310-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211310-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211310-001	AB	1	`301d65b070ca…`

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df61b895-c358-827b-e053-2995a90a9b60	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	3adfceb3-5f89-4bcf-b874-e3cb572a98b6	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	41876761-9d5b-4190-a200-6a822c54582e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	0c82422a-d493-4dda-8626-0d9baa25db8c	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca376622-d32c-4e6e-8af4-8e24a8d20d83	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	A-S Medication Solutions	be33f3cb-6fd1-4377-816e-84bd49370e9e	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	675f999d-46b2-45da-b17e-58cc2ba180b1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b1f1345c-3b7f-4228-b7b7-b9a4648050e5	2024-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	BluePoint Laboratories	a95cc04c-58e9-487f-8992-ef30df03a3cd	2024-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASE	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	41c86c02-68c0-4db5-af1a-941b0d2ffe11	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	3686cde5-f76d-4d16-aa5d-caceb8408f8c	2023-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	f5e7503a-b28f-4cd0-a4ee-47bdca88d54b	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	dcfd62c7-1687-4e9b-9ae4-5a44929ac765	2023-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASE	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	22a8cc15-17fb-4c4e-8d2a-de5755ed6031	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	51c342c9-b9c6-467d-8fea-b73d72e3febc	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	c34f6115-f447-450f-8c83-58f3c51a76c9	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b102b8e6-d58f-419c-bb35-720bafa13294	2020-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASE	DULOXETINE HYDROCHLORIDE	Proficient Rx LP	407b62b9-5b32-4bac-a2b0-7df499279248	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	db686a0a-9b2a-4017-8bd1-b981da47c2f3	2019-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.