Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022370
Company: CIPHER PHARMS INC
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 Prescription 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
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
10/07/2019 SUPPL-18 Labeling-Package Insert, Labeling-Medication Guide 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf
10/07/2019 SUPPL-18 Labeling-Medication Guide 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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