Application 208090

Type: NDA
Sponsor: COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XTAMPZA ER	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	9MG	Yes	No
002	XTAMPZA ER	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	13.5MG	Yes	No
003	XTAMPZA ER	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	18MG	Yes	No
004	XTAMPZA ER	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	27MG	Yes	No
005	XTAMPZA ER	OXYCODONE	CAPSULE, EXTENDED RELEASE;ORAL	36MG	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
N208090-001	XTAMPZA ER	OXYCODONE	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-002	XTAMPZA ER	OXYCODONE	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-003	XTAMPZA ER	OXYCODONE	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-004	XTAMPZA ER	OXYCODONE	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26
N208090-005	XTAMPZA ER	OXYCODONE	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208090-001	7771707	2028-10-09		Drug product	2016-07-19
N208090-001	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-001	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-001	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-001	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-001	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-001	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-001	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-002	7771707	2028-10-09		Drug product	2016-07-19
N208090-002	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-002	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-002	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-002	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-002	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-002	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-002	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-003	7771707	2028-10-09		Drug product	2016-07-19
N208090-003	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-003	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-003	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-003	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-003	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-003	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-003	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-004	7771707	2028-10-09		Drug product	2016-07-19
N208090-004	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-004	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-004	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-004	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-004	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-004	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-004	9968598	2036-09-02	U-1556	Drug product	2018-05-16
N208090-005	7771707	2028-10-09		Drug product	2016-07-19
N208090-005	10004729	2030-12-10	U-1556	Drug product	2018-07-10
N208090-005	10668060	2030-12-10	U-1556	Drug product	2020-06-03
N208090-005	9682075	2030-12-10	U-1556	Drug product	2017-06-20
N208090-005	10188644	2036-09-02	U-1556	Drug product	2019-01-29
N208090-005	10646485	2036-09-02	U-1556	Drug product	2020-05-13
N208090-005	9737530	2036-09-02	U-1556	Drug product	2017-08-23
N208090-005	9968598	2036-09-02	U-1556	Drug product	2018-05-16

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	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-001	XTAMPZA ER	9MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-002	XTAMPZA ER	13.5MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-003	XTAMPZA ER	18MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-004	XTAMPZA ER	27MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2016-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208090-005	XTAMPZA ER	36MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2016-04-26	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 80 · 3,180 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	N208090-001	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-001	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-002	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-003	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-004	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	7771707	2028-10-09		Drug product	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10004729	2030-12-10	U-1556	Drug product	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10668060	2030-12-10	U-1556	Drug product	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9682075	2030-12-10	U-1556	Drug product	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10188644	2036-09-02	U-1556	Drug product	2019-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	10646485	2036-09-02	U-1556	Drug product	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9737530	2036-09-02	U-1556	Drug product	2017-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208090-005	9968598	2036-09-02	U-1556	Drug product	2018-05-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208090-001	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-002	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-003	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-004	NP	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208090-005	NP	2019-04-26	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208090-001	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-002	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-003	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-004	NP	2019-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208090-005	NP	2019-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208090-001	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-002	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-003	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-004	NP	2019-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208090-005	NP	2019-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208090-001	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-002	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-003	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-004	NP	2019-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208090-005	NP	2019-04-26	`ea99ee380514…`

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
XTAMPZA ER	OXYCODONE	Collegium Pharmaceutical, Inc.	b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208090 application number: NDA208090 ndc (product): 24510-140 ndc (product): 24510-115 ndc (product): 24510-130 ndc (product): 24510-110 ndc (product): 24510-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24510-110	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-110	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-110	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-115	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-115	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-115	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-120	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-120	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-120	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-130	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-130	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-130	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-140	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-140	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
24510-140	XTAMPZA	OXYCODONE	Collegium Pharmaceutical, Inc.	NDA	Current
55700-557	XTAMPZA	OXYCODONE	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84640	SUPPL	2026-01-05
84581	SUPPL	2025-12-29
80094	SUPPL	2024-11-04
77057	SUPPL	2023-12-19
76998	SUPPL	2023-12-19
76962	SUPPL	2023-12-18
66657	SUPPL	2021-03-08
66656	SUPPL	2021-03-08
66502	SUPPL	2021-03-05
60433	SUPPL	2019-10-09
60432	SUPPL	2019-10-09
60368	SUPPL	2019-10-08
56180	SUPPL	2018-10-30
55702	SUPPL	2018-10-01
55701	SUPPL	2018-10-01
55528	SUPPL	2018-09-19
55527	SUPPL	2018-09-19
50351	SUPPL	2017-11-09
50317	SUPPL	2017-11-06
60820	SUPPL	2017-11-04
48586	SUPPL	2017-05-31
47584	ORIG	2017-03-17
46447	SUPPL	2016-12-21
46312	SUPPL	2016-12-20
45447	SUPPL	2016-10-03
24132	ORIG	2016-04-29
40616	ORIG	2016-04-27
32890	ORIG	2016-04-27
44603	ORIG	2015-11-06