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
COMTAN از شرکت ORION PHARMA
New Drug Application (NDA): 020796
Company: ORION PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMTAN | ENTACAPONE | 200MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 10/19/1999 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/22/2016 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf |
||
| 10/16/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-24 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020796Orig1s024ltr.pdf |
||
| 10/11/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2014 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf |
||
| 10/11/2010 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf |
||
| 02/02/2009 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf |
||
| 02/02/2009 | SUPPL-12 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf |
||
| 04/18/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/22/2016 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf | |
| 01/16/2015 | SUPPL-24 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf | |
| 06/13/2014 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf | |
| 10/11/2010 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf | |
| 02/02/2009 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf | |
| 02/02/2009 | SUPPL-12 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf | |
| 10/19/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF |
COMTAN
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COMTAN | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020796 | ORION PHARMA |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 205792 | AJANTA PHARMA LTD |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 078941 | ATLANTIDE |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 203437 | AUROBINDO PHARMA LTD |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 207210 | MACLEODS PHARMS LTD |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 090690 | SUN PHARM |
| ENTACAPONE | ENTACAPONE | 200MG | TABLET;ORAL | Prescription | No | AB | 206669 | SUNSHINE |
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