Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021123
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 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
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
10/07/2019 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide 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
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-Package Insert, Labeling-Medication Guide 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
10/07/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021123s019lbl.pdf
10/07/2019 SUPPL-19 Labeling-Medication Guide 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-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-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

ULTRACET

TABLET;ORAL; 325MG;37.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 202076 ALKEM LABS LTD
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 090485 AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 207152 AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 201952 MICRO LABS LTD INDIA
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 077858 MYLAN
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 077184 SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 090460 ZYDUS PHARMS USA INC
ULTRACET ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription Yes AB 021123 JANSSEN PHARMS

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