Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 100MG | 0 | ULTRAM | TRAMADOL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 50MG | 1 | ULTRAM | TRAMADOL HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-03-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1996-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1996-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1996-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1996-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-11-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1997-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1997-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 1998-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1998-08-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1999-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-08-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-03-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-03-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2001-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2004-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2009-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2009-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2017-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2019-04-08 | STANDARD |
| REMS; REMS | SUPPL | 42 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 43 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2021-09-10 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
TE Codes
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20281
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/020281s049lbl.pdf#page=43"]
[products] => [{"drugName":"ULTRAM","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ULTRAM","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020281s049lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2021","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020281s048lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020281s045lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020281s045lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020281s041lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020281s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020281s042s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-42","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020281s042s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2017","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020281s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020281s036s038lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020281s036s038lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020281s036s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020281s032s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020281s032s033lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2004","submission":"SUPPL-30","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":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20281s29lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/1999","submission":"SUPPL-16","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20281S16LBL.PDF\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ULTRAM","submission":"TRAMADOL HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ULTRAM","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-09-10
)
)