Home Applications 204031 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 44 .
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OXYCODONE HYDROCHLORIDE 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2014-03-11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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 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 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 534 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204031-001 7976870 2027-06-01 U-1498 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8372432 2029-03-11 U-1499 Drug product 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8394408 2029-03-11 Drug product 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8668929 2029-03-11 U-1499 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8377453 2029-11-19 U-1499 Drug product 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8597681 2030-12-21 Drug product 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8980319 2030-12-21 Drug product 2015-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8658631 2032-05-16 Drug product 2014-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8741885 2032-05-16 U-1499 Drug product 2014-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 8992975 2032-05-16 Drug product 2015-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 9050335 2032-05-16 Drug product 2015-06-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204031-001 9468636 2032-05-16 U-1499 2016-11-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204031-001 7976870 2027-06-01 U-1498 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8372432 2029-03-11 U-1499 Drug product 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8394408 2029-03-11 Drug product 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8668929 2029-03-11 U-1499 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8377453 2029-11-19 U-1499 Drug product 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8597681 2030-12-21 Drug product 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8980319 2030-12-21 Drug product 2015-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8658631 2032-05-16 Drug product 2014-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8741885 2032-05-16 U-1499 Drug product 2014-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 8992975 2032-05-16 Drug product 2015-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 9050335 2032-05-16 Drug product 2015-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204031-001 9468636 2032-05-16 U-1499 2016-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204031-001 7976870 2027-06-01 U-1498 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8372432 2029-03-11 U-1499 Drug product 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8394408 2029-03-11 Drug product 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8668929 2029-03-11 U-1499 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8377453 2029-11-19 U-1499 Drug product 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8597681 2030-12-21 Drug product 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8980319 2030-12-21 Drug product 2015-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8658631 2032-05-16 Drug product 2014-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8741885 2032-05-16 U-1499 Drug product 2014-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 8992975 2032-05-16 Drug product 2015-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 9050335 2032-05-16 Drug product 2015-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204031-001 9468636 2032-05-16 U-1499 2016-11-16 caaa826d4ba7…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…
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 · 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