Application 203794

Type: NDA
Sponsor: COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUCYNTA	TAPENTADOL HYDROCHLORIDE	SOLUTION;ORAL	EQ 20MG BASE/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203794-001	NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2012-10-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203794-001	NPP	2026-07-03
N203794-001	PED	2027-01-03

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203794-001	NUCYNTA	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2012-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203794-001	NUCYNTA	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD	2012-10-15	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203794-001	7994364*PED	2025-12-27		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203794-001	7994364	2025-06-27	U-1289	Drug substance, Drug product	2012-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203794-001	RE39593	2022-08-05	U-1289	Drug substance, Drug product	2012-10-24	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N203794-001	NPP	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203794-001	PED	2027-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203794-001	NPP	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203794-001	PED	2027-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203794-001	NPP	2026-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203794-001	PED	2027-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203794-001	NPP	2026-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203794-001	PED	2027-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203794-001	NPP	2026-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203794-001	PED	2027-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203794-001	NPP	2026-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203794-001	PED	2027-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203794-001	NPP	2026-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203794-001	PED	2027-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203794-001	NPP	2026-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203794-001	PED	2027-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203794-001	NPP	2026-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203794-001	PED	2027-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203794-001	NPP	2026-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203794-001	PED	2027-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203794-001	NPP	2026-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203794-001	PED	2027-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203794-001	NPP	2026-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203794-001	PED	2027-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203794-001	NPP	2026-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203794-001	NPP	2026-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203794-001	NPP	2026-07-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203794-001	NPP	2026-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203794-001	NPP	2026-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203794-001	NPP	2026-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203794-001	NPP	2026-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203794-001	NPP	2026-07-03	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203794-001	NPP	2026-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203794-001	PED	2027-01-03	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tapentadol Hydrochloride	TAPENTADOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	e0ecb809-6a55-4afe-b981-b8f174e5c344	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAPENTADOL HYDROCHLORIDE
TAPENTADOL	TAPENTADOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	863f3fd3-1e8d-41b0-855f-8f9a29237cda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAPENTADOL HYDROCHLORIDE
TAPENTADOL	TAPENTADOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	38de863e-56ff-4c43-9ab8-9b3e1ba82858	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAPENTADOL HYDROCHLORIDE
Tapentadol Hydrochloride	TAPENTADOL HYDROCHLORIDE	EPIC PHARMA LLC	fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAPENTADOL HYDROCHLORIDE
Nucynta ER	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	c3d04d70-0155-4147-9ce4-a3b1fad4b373	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TAPENTADOL HYDROCHLORIDE
Nucynta	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	80938c30-9fe3-4c7d-9d9c-5476638cfb2d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nucynta generic name: TAPENTADOL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84575	SUPPL	2025-12-29
84524	SUPPL	2025-12-23
80096	SUPPL	2024-11-04
78825	SUPPL	2024-06-18
78824	SUPPL	2024-06-18
78814	SUPPL	2024-06-18
77055	SUPPL	2023-12-19
76955	SUPPL	2023-12-18
76246	ORIG	2023-11-03
74692	SUPPL	2023-07-06
74687	SUPPL	2023-07-05
66649	SUPPL	2021-03-08
66648	SUPPL	2021-03-08
66609	SUPPL	2021-03-08
60427	SUPPL	2019-10-09
60425	SUPPL	2019-10-09
60373	SUPPL	2019-10-08
55724	SUPPL	2018-10-01
55723	SUPPL	2018-10-01
55557	SUPPL	2018-09-21
55556	SUPPL	2018-09-21
55555	SUPPL	2018-09-21
55554	SUPPL	2018-09-21
46430	SUPPL	2016-12-21
46301	SUPPL	2016-12-20
40328	SUPPL	2014-11-20
19493	SUPPL	2014-11-20
32468	SUPPL	2014-11-19
10251	SUPPL	2014-11-19
43444	ORIG	2012-11-16
24450	ORIG	2012-11-16
32467	ORIG	2012-10-18
43968	ORIG	2012-10-17
19492	ORIG	2012-10-17