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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022370
Company: CIPHER PHARMS INC

Medication Guide

REMS

Products on NDA 022370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONZIP	TRAMADOL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
CONZIP	TRAMADOL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CONZIP	TRAMADOL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CONZIP	TRAMADOL HYDROCHLORIDE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022370s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022370s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022370s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022370s000_tramadol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022370s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022370Orig1s025ltr.pdf
09/10/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022370Orig1s023ltr.pdf
03/04/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022370Orig1s020ltr.pdf
10/07/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022370Orig1s018ltr.pdf
09/18/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022370Orig1s016s017ltr.pdf
09/18/2018	SUPPL-16	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022370Orig1s016s017ltr.pdf
08/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022370Orig1s015ltr.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022370Orig1s012,s014ltr.pdf
07/09/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/16/2016	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022370Orig1s012,s014ltr.pdf
01/20/2015	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/05/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/13/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/09/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022370

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022370s025lbl.pdf
12/15/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022370s025lbl.pdf
09/10/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s023lbl.pdf
03/04/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s020lbl.pdf
10/07/2019	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf
10/07/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf
09/18/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf
09/18/2018	SUPPL-16	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf
08/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf
12/16/2016	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022370s012s014lbl.pdf
05/07/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022370s000lbl.pdf

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