Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020281
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRAM | TRAMADOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ULTRAM | TRAMADOL HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/03/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020281Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/10/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020281Orig1s049ltr.pdf | |
| 03/04/2021 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020281Orig1s048ltr.pdf | |
| 10/07/2019 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020281Orig1s045ltr.pdf | |
| 09/18/2018 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020281Orig1s042s043ltr.pdf | |
| 09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020281Orig1s042s043ltr.pdf | |
| 04/08/2019 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020281Orig1s041ltr.pdf | |
| 02/13/2023 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020281s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021123Orig1s015,020281Orig1s040ltr.pdf | |
| 08/29/2017 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020281Orig1s039ltr.pdf | |
| 12/16/2016 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020281Orig1s036,s038ltr.pdf | |
| 12/16/2016 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020281Orig1s036,s038ltr.pdf | |
| 09/09/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf | |
| 09/09/2009 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf | |
| 04/16/2004 | SUPPL-30 | 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 | |
| 08/15/2001 | SUPPL-29 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20281s29lbl.pdf | |
| 02/13/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-16 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20281S16LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20281S16LTR.PDF | |
| 08/21/1998 | SUPPL-15 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S015_ULTRAM_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s015_ultram_toc.cfm |
| 08/21/1998 | SUPPL-14 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S014_ULTRAM_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s014_ultram_toc.cfm |
| 11/20/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/30/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/13/2023 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020281s040lbl.pdf | |
| 09/10/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s049lbl.pdf | |
| 03/04/2021 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s048lbl.pdf | |
| 10/07/2019 | SUPPL-45 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s045lbl.pdf | |
| 10/07/2019 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s045lbl.pdf | |
| 04/08/2019 | SUPPL-41 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s041lbl.pdf | |
| 04/08/2019 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020281s041lbl.pdf | |
| 09/18/2018 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf | |
| 09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf | |
| 08/29/2017 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s039lbl.pdf | |
| 12/16/2016 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf | |
| 12/16/2016 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf | |
| 12/16/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020281s036s038lbl.pdf | |
| 09/09/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf | |
| 09/09/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf | |
| 04/16/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf | |
| 08/15/2001 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20281s29lbl.pdf | |
| 12/23/1999 | SUPPL-16 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20281S16LBL.PDF |