Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021123
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ULTRACET | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/15/2001 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/10/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021123Orig1s021ltr.pdf | |
03/04/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021123Orig1s020ltr.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021123s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021123Orig1s019ltr.pdf | |
09/18/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021123IOrig1s016s017ltr.pdf | |
09/18/2018 | SUPPL-16 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021123IOrig1s016s017ltr.pdf | |
02/13/2023 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021123s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021123Orig1s015,020281Orig1s040ltr.pdf | |
08/29/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021123Orig1s014ltr.pdf | |
12/16/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf | |
12/16/2016 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf | |
12/16/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021123Orig1s010,s012,s013tr.pdf | |
10/18/2013 | SUPPL-8 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021123Orig1s008ltr.pdf | |
06/22/2011 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021123s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021123s005ltr.pdf | |
09/09/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021123s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021123s003ltr.pdf | |
04/16/2004 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/13/2023 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021123s015lbl.pdf | |
09/10/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s021lbl.pdf | |
03/04/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s020lbl.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021123s019lbl.pdf | |
10/07/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021123s019lbl.pdf | |
09/18/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s016s017lbl.pdf | |
09/18/2018 | SUPPL-16 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s016s017lbl.pdf | |
08/29/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf | |
12/16/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf | |
12/16/2016 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf | |
12/16/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf | |
12/16/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021123s010s012s013lbl.pdf | |
10/18/2013 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf | |
10/18/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf | |
06/22/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021123s005lbl.pdf | |
09/09/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021123s003lbl.pdf | |
04/16/2004 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf | |
08/15/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21123lbl.pdf |