U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020281
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ULTRAM TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
ULTRAM TRAMADOL HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
Back to Top