Application 207621

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	1.2MG;10MG	No	No
002	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	2.4MG;20MG	No	No
003	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	3.6MG;30MG	No	No
004	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	4.8MG;40MG	No	No
005	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7.2MG;60MG	No	No
006	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	9.6MG;80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N207621-001	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19
N207621-002	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19
N207621-003	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19
N207621-004	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19
N207621-005	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19
N207621-006	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N207621-001	7815934	2027-12-12	Drug product	2016-09-16
N207621-002	7815934	2027-12-12	Drug product	2016-09-16
N207621-003	7815934	2027-12-12	Drug product	2016-09-16
N207621-004	7815934	2027-12-12	Drug product	2016-09-16
N207621-005	7815934	2027-12-12	Drug product	2016-09-16
N207621-006	7815934	2027-12-12	Drug product	2016-09-16

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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-005	TROXYCA ER	7.2MG;60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207621-006	TROXYCA ER	9.6MG;80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207621-001	TROXYCA ER	1.2MG;10MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207621-002	TROXYCA ER	2.4MG;20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207621-003	TROXYCA ER	3.6MG;30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207621-004	TROXYCA ER	4.8MG;40MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-08-19	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 480 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	N207621-001	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-002	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-003	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-004	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-005	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207621-006	7815934	2027-12-12		Drug product	2016-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-001	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-001	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-002	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-002	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-003	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-003	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-004	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-004	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-005	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-005	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-006	8685443	2025-07-03	U-1508		2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207621-006	7815934	2027-12-12		Drug product	2016-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207621-001	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-001	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-002	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-002	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-003	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-003	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-004	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-004	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-005	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-005	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-006	8685443	2025-07-03	U-1508		2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207621-006	7815934	2027-12-12		Drug product	2016-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-001	8685443	2025-07-03	U-1508		2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-001	7815934	2027-12-12		Drug product	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-002	8685443	2025-07-03	U-1508		2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-002	7815934	2027-12-12		Drug product	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-003	8685443	2025-07-03	U-1508		2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-003	7815934	2027-12-12		Drug product	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-004	8685443	2025-07-03	U-1508		2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-004	7815934	2027-12-12		Drug product	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-005	8685443	2025-07-03	U-1508		2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207621-005	7815934	2027-12-12		Drug product	2016-09-16	`fd3edfee7708…`

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	N207621-001	NC	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207621-002	NC	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207621-003	NC	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207621-004	NC	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207621-005	NC	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207621-006	NC	2019-08-19	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N207621-001	NC	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207621-002	NC	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207621-003	NC	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207621-004	NC	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207621-005	NC	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207621-006	NC	2019-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207621-001	NC	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207621-002	NC	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207621-003	NC	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207621-004	NC	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207621-005	NC	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207621-006	NC	2019-08-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207621-001	NC	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207621-002	NC	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207621-003	NC	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207621-004	NC	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207621-005	NC	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207621-006	NC	2019-08-19	`ea99ee380514…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48590	SUPPL	2017-05-31
46581	SUPPL	2016-12-29
46444	SUPPL	2016-12-21
46317	SUPPL	2016-12-20
46080	ORIG	2016-12-06
46079	ORIG	2016-12-06
45821	APPL	2016-11-04
45568	ORIG	2016-10-20
45450	SUPPL	2016-10-03
45369	ORIG	2016-09-21
45368	ORIG	2016-09-21
45047	ORIG	2016-08-19
45041	ORIG	2016-08-19