Application 204031

Type: NDA
Sponsor: MALLINCKRODT INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XARTEMIS XR	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	325MG;7.5MG	Yes	No

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

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
N204031-001	XARTEMIS XR	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-03-11

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204031-001	7976870	2027-06-01	U-1498		2014-04-03
N204031-001	8372432	2029-03-11	U-1499	Drug product	2014-04-03
N204031-001	8394408	2029-03-11		Drug product	2014-04-03
N204031-001	8668929	2029-03-11	U-1499		2014-04-03
N204031-001	8377453	2029-11-19	U-1499	Drug product	2014-04-03
N204031-001	8597681	2030-12-21		Drug product	2014-04-03
N204031-001	8980319	2030-12-21		Drug product	2015-04-03
N204031-001	8658631	2032-05-16		Drug product	2014-04-03
N204031-001	8741885	2032-05-16	U-1499	Drug product	2014-06-17
N204031-001	8992975	2032-05-16		Drug product	2015-04-03
N204031-001	9050335	2032-05-16		Drug product	2015-06-25
N204031-001	9468636	2032-05-16	U-1499		2016-11-16

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 2 · 41 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UTC	2026-02	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204031-001	XARTEMIS XR	325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204031-001	XARTEMIS XR	325MG;7.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2014-03-11	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 498 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	N204031-001	7976870	2027-06-01	U-1498		2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8372432	2029-03-11	U-1499	Drug product	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8394408	2029-03-11		Drug product	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8668929	2029-03-11	U-1499		2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8377453	2029-11-19	U-1499	Drug product	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8597681	2030-12-21		Drug product	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8980319	2030-12-21		Drug product	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8658631	2032-05-16		Drug product	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8741885	2032-05-16	U-1499	Drug product	2014-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	8992975	2032-05-16		Drug product	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	9050335	2032-05-16		Drug product	2015-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204031-001	9468636	2032-05-16	U-1499		2016-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	7976870	2027-06-01	U-1498		2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8372432	2029-03-11	U-1499	Drug product	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8394408	2029-03-11		Drug product	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8668929	2029-03-11	U-1499		2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8377453	2029-11-19	U-1499	Drug product	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8597681	2030-12-21		Drug product	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8980319	2030-12-21		Drug product	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8658631	2032-05-16		Drug product	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8741885	2032-05-16	U-1499	Drug product	2014-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	8992975	2032-05-16		Drug product	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	9050335	2032-05-16		Drug product	2015-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204031-001	9468636	2032-05-16	U-1499		2016-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204031-001	7976870	2027-06-01	U-1498		2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8372432	2029-03-11	U-1499	Drug product	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8394408	2029-03-11		Drug product	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8668929	2029-03-11	U-1499		2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8377453	2029-11-19	U-1499	Drug product	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8597681	2030-12-21		Drug product	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8980319	2030-12-21		Drug product	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8658631	2032-05-16		Drug product	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8741885	2032-05-16	U-1499	Drug product	2014-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	8992975	2032-05-16		Drug product	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	9050335	2032-05-16		Drug product	2015-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204031-001	9468636	2032-05-16	U-1499		2016-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204031-001	7976870	2027-06-01	U-1498		2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204031-001	8372432	2029-03-11	U-1499	Drug product	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204031-001	8394408	2029-03-11		Drug product	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204031-001	8668929	2029-03-11	U-1499		2014-04-03	`fd3edfee7708…`

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23635-115	Xartemis	oxycodone hydrochloride and acetaminophen	SpecGx LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55665	SUPPL	2018-09-28
55664	SUPPL	2018-09-28
55553	SUPPL	2018-09-21
55552	SUPPL	2018-09-21
55551	SUPPL	2018-09-21
55550	SUPPL	2018-09-21
46431	SUPPL	2016-12-21
46300	SUPPL	2016-12-20
40344	SUPPL	2015-03-17
10285	SUPPL	2015-03-13
43453	ORIG	2014-04-18
19515	ORIG	2014-03-13
10284	ORIG	2014-03-13