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
CONTRAVE از شرکت NALPROPION
New Drug Application (NDA): 200063
Company: NALPROPION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | 90MG;8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/10/2014 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2021 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200063Orig1s020ltr.pdf |
||
| 08/04/2020 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200063Orig1s015ltr.pdf |
||
| 06/13/2018 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200063Orig1s013ltr.pdf |
||
| 05/04/2017 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1sS009ltr.pdf |
||
| 03/10/2017 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200063Orig1s006ltr.pdf |
||
| 01/27/2017 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/2017 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 04/14/2021 | SUPPL-20 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf | |
| 04/14/2021 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf | |
| 08/04/2020 | SUPPL-15 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf | |
| 08/04/2020 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf | |
| 06/13/2018 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf | |
| 05/04/2017 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s009lbl.pdf | |
| 03/10/2017 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200063s006lbl.pdf | |
| 09/10/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf |
نظرات کاربران