Application 200533

Type: NDA
Sponsor: COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	Yes	No
002	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	Yes	No
003	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	Yes	No
004	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	Yes	No
005	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N200533-001	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-002	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-003	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-004	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-005	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200533-001	11344512	2028-04-21	U-3391		2022-06-29
N200533-001	11344512	2028-04-21	U-3392		2022-06-29
N200533-001	8536130	2028-09-22	U-1276
N200533-001	11344512*PED	2028-10-21		Pediatric extension
N200533-001	8536130*PED	2029-03-22		Pediatric extension
N200533-002	11344512	2028-04-21	U-3391		2022-06-29
N200533-002	11344512	2028-04-21	U-3392		2022-06-29
N200533-002	8536130	2028-09-22	U-1276
N200533-002	11344512*PED	2028-10-21		Pediatric extension
N200533-002	8536130*PED	2029-03-22		Pediatric extension
N200533-003	11344512	2028-04-21	U-3391		2022-06-29
N200533-003	11344512	2028-04-21	U-3392		2022-06-29
N200533-003	8536130	2028-09-22	U-1276
N200533-003	11344512*PED	2028-10-21		Pediatric extension
N200533-003	8536130*PED	2029-03-22		Pediatric extension
N200533-004	11344512	2028-04-21	U-3391		2022-06-29
N200533-004	11344512	2028-04-21	U-3392		2022-06-29
N200533-004	8536130	2028-09-22	U-1276
N200533-004	11344512*PED	2028-10-21		Pediatric extension
N200533-004	8536130*PED	2029-03-22		Pediatric extension
N200533-005	11344512	2028-04-21	U-3391		2022-06-29
N200533-005	11344512	2028-04-21	U-3392		2022-06-29
N200533-005	8536130	2028-09-22	U-1276
N200533-005	11344512*PED	2028-10-21		Pediatric extension
N200533-005	8536130*PED	2029-03-22		Pediatric extension

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 50 · 1,980 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1276	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1178	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1178	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1276	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAPENTADOL	TAPENTADOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	38de863e-56ff-4c43-9ab8-9b3e1ba82858	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533
Nucynta ER	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	c3d04d70-0155-4147-9ce4-a3b1fad4b373	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533 ndc (product): 24510-116 ndc (product): 24510-291 ndc (product): 24510-058 ndc (product): 24510-174 ndc (product): 24510-232

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24510-058	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-058	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-058	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-058	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-058	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-116	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-116	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-116	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-116	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-116	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-174	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-174	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-174	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-174	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-174	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-232	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-232	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-232	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-232	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-232	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-291	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-291	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-291	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-291	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-291	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
50458-860	Nucynta	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-861	Nucynta	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-862	Nucynta	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-863	Nucynta	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-864	Nucynta	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
55700-555	Nucynta	tapentadol hydrochloride	LAKE ERIE MEDICAL DBA QUA	NDA	Current
55700-555	Nucynta	tapentadol hydrochloride	LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC	NDA	Current
55700-565	Nucynta	tapentadol hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-796	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
55700-796	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
55700-796	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
55700-797	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
55700-797	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
55700-797	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
69865-240	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-245	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-250	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-260	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-265	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84534	SUPPL	2025-12-23
84525	SUPPL	2025-12-23
80079	SUPPL	2024-11-04
80078	SUPPL	2024-11-04
78823	SUPPL	2024-06-18
78822	SUPPL	2024-06-18
78813	SUPPL	2024-06-18
77070	SUPPL	2023-12-19
76943	SUPPL	2023-12-18
66627	SUPPL	2021-03-08
66626	SUPPL	2021-03-08
66570	SUPPL	2021-03-08
60393	SUPPL	2019-10-08
60392	SUPPL	2019-10-08
60378	SUPPL	2019-10-08
55693	SUPPL	2018-10-01
55692	SUPPL	2018-10-01
55590	SUPPL	2018-09-24
55589	SUPPL	2018-09-24
48583	SUPPL	2017-05-31
46411	SUPPL	2016-12-21
46328	SUPPL	2016-12-20
45456	SUPPL	2016-10-03
9827	SUPPL	2016-04-22
32030	SUPPL	2015-07-07
32029	SUPPL	2014-08-20
32028	SUPPL	2014-04-17
40024	SUPPL	2014-04-16
32027	SUPPL	2013-04-18
40023	SUPPL	2012-08-29
32025	SUPPL	2012-08-29
18962	SUPPL	2012-07-12
32026	SUPPL	2012-07-11
43346	ORIG	2012-04-12
24095	ORIG	2011-08-30
32024	ORIG	2011-08-29
18961	ORIG	2011-08-26