Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022370
Company: CIPHER PHARMS INC
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 | Discontinued | 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 |
---|---|---|---|---|---|
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-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 |
---|---|---|---|---|---|
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-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 |