Application 209777

Type: NDA
Sponsor: INSPIRION DELIVERY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROXYBOND	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	ROXYBOND	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
003	ROXYBOND	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
004	ROXYBOND	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N209777-001	ROXYBOND	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-04-20
N209777-002	ROXYBOND	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-04-20
N209777-003	ROXYBOND	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-04-20
N209777-004	ROXYBOND	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2024-09-05

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N209777-001	10314788	2028-08-12	Drug product	2019-07-10
N209777-001	7955619	2028-08-12	Drug product	2017-05-19
N209777-002	10314788	2028-08-12	Drug product	2019-07-10
N209777-002	7955619	2028-08-12	Drug product	2017-05-19
N209777-003	10314788	2028-08-12	Drug product	2019-07-10
N209777-003	7955619	2028-08-12	Drug product	2017-05-19
N209777-004	10314788	2028-08-12	Drug product	2024-10-04
N209777-004	7955619	2028-08-12	Drug product	2024-10-04

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 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`6a471c1ec25d…`

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	N209777-001	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-002	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-003	NP	2020-04-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209777-001	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-002	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-003	NP	2020-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209777-001	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-002	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-003	NP	2020-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209777-001	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-002	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-003	NP	2020-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209777-001	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-002	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-003	NP	2020-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209777-001	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-002	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-003	NP	2020-04-20	`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
RoxyBond	OXYCODONE HYDROCHLORIDE	Protega Pharmaceuticals Inc	72398542-8e0a-47b2-afeb-9ca5a1f15083	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209777 application number: NDA209777 ndc (product): 81140-103 ndc (product): 81140-102 ndc (product): 81140-101

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65597-501	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-501	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-502	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-502	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-503	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-503	Roxybond	oxycodone hydrochloride	Daiichi Sankyo Inc.	NDA	Current
81140-101	RoxyBond	Oxycodone hydrochloride	Protega Pharmaceuticals LLC	NDA	Current
81140-102	RoxyBond	Oxycodone hydrochloride	Protega Pharmaceuticals LLC	NDA	Current
81140-103	RoxyBond	Oxycodone hydrochloride	Protega Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84641	SUPPL	2026-01-05
84583	SUPPL	2025-12-29
81508	SUPPL	2025-03-11
81503	SUPPL	2025-03-11
81502	SUPPL	2025-03-10
81501	SUPPL	2025-03-10
80085	SUPPL	2024-11-04
78221	SUPPL	2024-04-23
78191	SUPPL	2024-04-19
77081	SUPPL	2023-12-19
76986	SUPPL	2023-12-19
76041	ORIG	2023-11-02
66531	SUPPL	2021-03-05
66530	SUPPL	2021-03-05
66529	SUPPL	2021-03-05
60456	SUPPL	2019-10-09
60455	SUPPL	2019-10-09
60356	SUPPL	2019-10-08
57124	SUPPL	2019-01-04
57090	SUPPL	2019-01-02
55708	SUPPL	2018-10-01
55707	SUPPL	2018-10-01
55515	SUPPL	2018-09-19
55514	SUPPL	2018-09-19
49665	ORIG	2017-09-05
48087	ORIG	2017-04-24
48086	ORIG	2017-04-24
48085	ORIG	2017-04-24
48084	ORIG	2017-04-24