اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CONZIP از شرکت CIPHER PHARMS INC
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 | 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022370s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-20 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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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