Acetaminophen / Oxycodone Extended Release Oral Tablet
- Brand(s)
- Xartemis
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Mallinckrodt, Inc (2015-03-31)
- Oldest Current Product
- 2013-04-30
- License(s)
- NDA
- RxNORM
- EXTENDED RELEASE ORAL TABLET\ACETAMINOPHEN:OXYCODONE
- FDAOB
- ORAL\TABLET, EXTENDED RELEASE\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET, COATED\ACETAMINOPHEN: OXYCODONE HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET, COATED\ACETAMINOPHEN: OXYCODONE
product(s) by strength(s)
12 hr acetaminophen 325 mg / oxycodone hydrochloride 7.5 mg extended release oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 236350115 | Xartemis | NDA | Mallinckrodt, Inc | 2013-04-30 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | TABLET, COATED | NDA204031 | efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 430630531 | Xartemis | NDA | Pd-Rx Pharmaceuticals, Inc. | 2013-04-30 | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE | ORAL | TABLET, COATED | 236350115 | NDA204031 | 6beb5fe9-ff58-4fa6-bd69-7790412bdb06 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA204031 | XARTEMIS XR | MALLINCKRODT INC | 2014-03-11 | p8394408, SUBSTANCE p8992975, SUBSTANCE p8597681, SUBSTANCE p8372432, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE p7976870, METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM p8741885, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE p8658631, SUBSTANCE p8668929, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA p8980319, SUBSTANCE p8377453, MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA, SUBSTANCE p9050335, SUBSTANCE p6488962, SUBSTANCE | NEW PRODUCT [2017-03-11] | NDA204031_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA204031_001 | RX | OXYCODONE HYDROCHLORIDE (7.5MG), ACETAMINOPHEN (325MG) | ORAL | TABLET, EXTENDED RELEASE | True | 2014-03-11 | XARTEMIS XR |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6488962 (view patent) | 2020-06-20 | NDA204031, NDA021744, NDA021748, NDA022544 | Ciprofloxacin Extended Release Oral Tablet gabapentin Oral Tablet Metformin Extended Release Oral Tablet gabapentin Oral Capsule |
| 2 | p7976870 (view patent) | 2027-06-01 | NDA204031 | |
| 3 | p8372432 (view patent) | 2029-03-11 | NDA204031 | |
| 4 | p8377453 (view patent) | 2029-11-19 | NDA204031 | |
| 5 | p8394408 (view patent) | 2029-03-11 | NDA204031 | |
| 6 | p8597681 (view patent) | 2030-12-21 | NDA204031 | |
| 7 | p8658631 (view patent) | 2032-05-16 | NDA204031 | |
| 8 | p8668929 (view patent) | 2029-03-11 | NDA204031 | |
| 9 | p8741885 (view patent) | 2032-05-16 | NDA204031 | |
| 10 | p8980319 (view patent) | 2030-12-21 | NDA204031 | |
| 11 | p8992975 (view patent) | 2032-05-16 | NDA204031 | |
| 12 | p9050335 (view patent) | 2032-05-16 | NDA204031 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 6beb5fe9-ff58-4fa6-bd69-7790412bdb06 (view SPL) | These highlights do not include all the information needed to use XARTEMISXR safely and effectively. See full prescribing information for XARTEMISXR. XARTEMISXR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, for oral use,CII Initial U.S. Approval: 1976 | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2014-03-12 | 3 | 430630531 |
| 2 | efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd (view SPL) | These highlights do not include all the information needed to use XARTEMISXR safely and effectively. See full prescribing information for XARTEMISXR. XARTEMISXR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, for oral use,CII Initial U.S. Approval: 1976 | prescription | Human Prescription | Mallinckrodt, Inc | 2015-03-31 | 9 | 236350115 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII