Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 325MG;37.5MG | 1 | ULTRACET | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2001-08-15 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2009-09-09 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2011-06-22 | UNKNOWN |
LABELING; Labeling | SUPPL | 8 | AP | 2013-10-18 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 10 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2017-08-29 | STANDARD |
REMS; REMS | SUPPL | 16 | AP | 2018-09-18 | N/A |
LABELING; Labeling | SUPPL | 17 | AP | 2018-09-18 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2019-10-07 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2021-03-04 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2021-09-10 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 6 |
SUPPL | 5 | Null | 6 |
SUPPL | 8 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 12 | Null | 7 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 15 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 15 |
SUPPL | 19 | Null | 15 |
SUPPL | 20 | Null | 15 |
SUPPL | 21 | Null | 7 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21123
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021123s021lbl.pdf#page=46"]
[products] => [{"drugName":"ULTRACET","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021123s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2021","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021123s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021123s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021123s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021123s016s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-16","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021123s016s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021123s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021123s010s012s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021123s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021123s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021123s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021123s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20281slr030,21123slr001_Ultram_lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21123lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ULTRACET","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-09-10
)
)