Drugs@FDA: FDA Approved Drug Products

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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 TABLET;ORAL Discontinued None No No
ULTRAM TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB Yes Yes
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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
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

ULTRAM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202390 ACCORD HLTHCARE
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202075 ACI HEALTHCARE LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076003 AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075981 APOTEX
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 203494 AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091498 CSPC OUYI PHARM CO
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 201973 IPCA LABS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205702 MACLEODS PHARMS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075983 MALLINCKRODT
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075986 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075980 MYLAN PHARMS INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075982 PLIVA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076100 SUN PHARM INDS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075964 SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075977 TEVA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 090404 ZYDUS PHARMS USA INC
ULTRAM TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 020281 JANSSEN PHARMS

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