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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021123
Company: JANSSEN PHARMS

Medication Guide

REMS

Products on NDA 021123

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021123

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

Labels for NDA 021123

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

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