Application 021427

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYMBALTA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	Yes	No
002	CYMBALTA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 30MG BASE	Yes	No
004	CYMBALTA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG BASE	Yes	Yes

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	RLD / RS	Approval date
N021427-001	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03
N021427-002	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03
N021427-004	CYMBALTA	DULOXETINE HYDROCHLORIDE	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	RLD	2004-08-03

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	2004-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021427-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021427-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021427-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021427-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021427-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021427-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021427-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021427-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021427-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021427-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021427-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021427-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021427-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021427-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021427-001	AB	1	`5d02ea3f76ae…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021427-001	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-002	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-004	6596756	2019-09-10	U-882		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021427-001	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-002	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-004	6596756	2019-09-10	U-882		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021427-001	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-002	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-004	6596756	2019-09-10	U-882		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021427-001	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-001	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-002	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-002	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-004	6596756	2019-09-10	U-882		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021427-004	6596756*PED	2020-03-10		Pediatric extension	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021427-002	NPP	2023-04-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021427-004	NPP	2023-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021427-001	NPP	2023-04-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021427-002	NPP	2023-04-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021427-004	NPP	2023-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021427-001	NPP	2023-04-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021427-002	NPP	2023-04-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021427-004	NPP	2023-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021427-001	NPP	2023-04-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021427-002	NPP	2023-04-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021427-004	NPP	2023-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021427-001	NPP	2023-04-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021427-002	NPP	2023-04-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021427-004	NPP	2023-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021427-001	NPP	2023-04-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021427-002	NPP	2023-04-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021427-004	NPP	2023-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021427-001	NPP	2023-04-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021427-002	NPP	2023-04-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021427-004	NPP	2023-04-20	`cb3db0bc1861…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	00628e5e-4c5b-2573-e063-6294a90a0e3b	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	Yaopharma Co., Ltd.	90224073-178d-7ec5-e053-2995a90a20fc	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	REMEDYREPACK INC.	b9f20917-9529-4c62-bafe-baae7f8d6c77	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	29eacc40-cbec-4cc9-8556-773346617e85	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine	DULOXETINE HYDROCHLORIDE	Quallent Pharmaceuticals Health, LLC	31362045-201f-45f3-99f2-a5e322a0c30b	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Hydrochloride	DULOXETINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	177ce798-3924-416b-ba37-23dfa911a43b	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3bae1317-4cc8-4d86-b1b6-15edee733a6d	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2c233b3f-83de-40c4-9f1d-81f901f89459	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	f66f63c8-51db-4183-a452-78205cf3a263	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	276ca221-354c-484d-93d5-0698cb2cfd56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a23e79b3-7bd3-4b83-beb0-dc23d4830e9e	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a5804a0b-ceae-4ebd-bba0-bfc10e21b90d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	a891f20f-83ff-4960-81ef-9e74d01a452e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c934cc41-b40b-4c5c-b019-a749eec52d88	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	ca36f94c-2215-436f-ada8-7319f4f3e054	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	b25c01e0-273a-4f8f-a37e-9b17e5cf378f	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-Release	DULOXETINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	caef6f50-1571-4ec7-8f8c-42b924d323ee	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DULOXETINE HYDROCHLORIDE
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3235	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3240	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
0002-3270	Cymbalta	Duloxetine hydrochloride	Eli Lilly and Company	NDA	Current
21695-145	Cymbalta	Duloxetine hydrochloride	Rebel Distributors Corp.	NDA	Current
21695-146	Cymbalta	Duloxetine hydrochloride	Rebel Distributors Corp.	NDA	Current
21695-657	Cymbalta	Duloxetine hydrochloride	Rebel Distributors Corp	NDA	Current
35356-843	Cymbalta	Duloxetine hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
43353-303	Cymbalta	Duloxetine hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
49999-618	Cymbalta	Duloxetine hydrochloride	Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC	NDA	Current
52959-892	Cymbalta	Duloxetine hydrochloride	H.J. Harkins Company, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-028	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-036	Cymbalta	Duloxetine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68151-4679	Cymbalta	Duloxetine hydrochloride	Carilion Materials Management	NDA	Current
68151-4727	Duloxetine	Duloxetine hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-4734	Cymbalta	Duloxetine hydrochloride	Carilion Materials Management	NDA	Current
70518-2099	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2099	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2099	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2099	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2100	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2100	Cymbalta	Duloxetine hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75257	SUPPL	2023-08-22
75256	SUPPL	2023-08-22
75152	SUPPL	2023-08-21
75151	SUPPL	2023-08-21
75150	SUPPL	2023-08-21
68701	SUPPL	2021-09-21
68700	SUPPL	2021-09-21
68686	SUPPL	2021-09-21
64868	SUPPL	2020-10-07
64799	SUPPL	2020-10-02
62618	SUPPL	2020-04-21
62617	SUPPL	2020-04-21
62613	SUPPL	2020-04-21
60435	SUPPL	2019-10-09
60262	SUPPL	2019-10-07
60261	SUPPL	2019-10-07
50896	SUPPL	2017-12-27
50806	SUPPL	2017-12-21
46735	SUPPL	2017-01-10
46734	SUPPL	2017-01-10
46686	SUPPL	2017-01-06
45197	SUPPL	2016-09-02
45196	SUPPL	2016-09-02
5341	SUPPL	2015-06-22
15440	SUPPL	2015-06-19
36890	SUPPL	2014-12-03
36887	SUPPL	2014-12-03
27740	SUPPL	2014-11-28
5339	SUPPL	2014-11-28
36892	SUPPL	2014-10-21
36891	SUPPL	2014-10-21
27743	SUPPL	2014-10-21
5340	SUPPL	2014-10-21
15439	SUPPL	2014-07-28
27744	SUPPL	2014-07-21
36889	SUPPL	2012-10-22
15438	SUPPL	2012-10-22
5338	SUPPL	2012-10-22
5337	SUPPL	2012-10-22
36888	SUPPL	2012-08-30
36886	SUPPL	2012-08-30
27741	SUPPL	2012-08-28
27738	SUPPL	2012-08-28
21649	SUPPL	2012-05-09
42152	SUPPL	2011-10-10
42151	SUPPL	2011-10-10
27742	SUPPL	2011-09-07
15437	SUPPL	2011-09-07
27739	SUPPL	2011-04-15
15436	SUPPL	2011-04-15
5336	SUPPL	2011-03-08
36885	SUPPL	2011-03-07
5335	SUPPL	2009-11-27
36884	SUPPL	2009-11-23
51519	SUPPL	2009-11-02
51518	SUPPL	2009-09-22
27736	SUPPL	2009-03-24
5334	SUPPL	2009-03-24
5333	SUPPL	2009-03-24
36883	SUPPL	2009-03-20
15434	SUPPL	2009-03-20
15433	SUPPL	2009-03-20
15435	SUPPL	2009-02-04
27737	SUPPL	2009-02-03
36882	SUPPL	2007-12-03
15431	SUPPL	2007-12-03
5332	SUPPL	2007-12-03
5331	SUPPL	2007-12-03
27735	SUPPL	2007-08-07
15432	SUPPL	2007-08-03
27734	SUPPL	2007-03-06
5330	SUPPL	2007-03-06
5329	SUPPL	2007-03-06
36881	SUPPL	2007-02-26
15430	SUPPL	2007-02-26
15428	SUPPL	2007-02-26
15429	SUPPL	2006-09-21
51517	SUPPL	2006-06-23
5328	SUPPL	2006-06-14
23658	ORIG	2005-07-29
5327	SUPPL	2005-02-23
42150	ORIG	2004-10-08
15427	ORIG	2004-08-10
5326	ORIG	2004-08-10
63904	ORIG	1900-01-01
63903	ORIG	1900-01-01
63902	ORIG	1900-01-01
53532	ORIG	1900-01-01
52895	ORIG	1900-01-01
52443	SUPPL	1900-01-01
52441	SUPPL	1900-01-01
52439	ORIG	1900-01-01
52438	ORIG	1900-01-01