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 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	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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-002	CYMBALTA	EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021427-004	CYMBALTA	EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2004-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021427-001	CYMBALTA	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2004-08-03	`8072bd15b7f6…`

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 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-001	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-002	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021427-004	NPP	2023-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021427-001	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021427-002	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021427-004	NPP	2023-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021427-001	NPP	2023-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-002	NPP	2023-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021427-004	NPP	2023-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021427-001	NPP	2023-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-002	NPP	2023-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021427-004	NPP	2023-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021427-001	NPP	2023-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-002	NPP	2023-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021427-004	NPP	2023-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-001	NPP	2023-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-002	NPP	2023-04-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021427-004	NPP	2023-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021427-001	NPP	2023-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-002	NPP	2023-04-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021427-004	NPP	2023-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021427-001	NPP	2023-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-002	NPP	2023-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021427-004	NPP	2023-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021427-001	NPP	2023-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-002	NPP	2023-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021427-004	NPP	2023-04-20	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N021427-001	NPP	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021427-002	NPP	2023-04-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021427-004	NPP	2023-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-001	NPP	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-002	NPP	2023-04-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021427-004	NPP	2023-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-001	NPP	2023-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-002	NPP	2023-04-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021427-004	NPP	2023-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-001	NPP	2023-04-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-002	NPP	2023-04-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021427-004	NPP	2023-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021427-001	NPP	2023-04-20	`3f0d92c62455…`

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
Cymbalta	DULOXETINE HYDROCHLORIDE	Eli Lilly and Company	2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021427 application number: NDA021427 ndc (product): 0002-3270 ndc (product): 0002-3240 ndc (product): 0002-3235

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