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
COLCRYS از شرکت TAKEDA PHARMS USA
New Drug Application (NDA): 022352
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLCRYS | COLCHICINE | 0.6MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/2009 | ORIG-1 | Approval |
Type 7 – Drug Already Marketed without Approved NDA |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2020 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022352Orig1s026ltr.pdf |
||
| 12/22/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2015 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022352Orig1s022ltr.pdf |
||
| 11/25/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2014 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022352Orig1s017ltr.pdf |
||
| 07/20/2011 | SUPPL-14 | Labeling-Medication Guide, REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf |
||
| 07/20/2011 | SUPPL-13 | REMS-Assessment |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf |
||
| 04/29/2010 | SUPPL-4 | REMS-Modified, Labeling-Container/Carton Labels, REMS-Assessment, REMS-Proposal |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022352s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2020 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf | |
| 12/17/2015 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf | |
| 08/14/2014 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf | |
| 07/20/2011 | SUPPL-14 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf | |
| 07/20/2011 | SUPPL-14 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf | |
| 07/20/2011 | SUPPL-13 |
REMS-Assessment |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf | |
| 04/29/2010 | SUPPL-4 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf | |
| 04/29/2010 | SUPPL-4 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf | |
| 04/29/2010 | SUPPL-4 |
REMS-Assessment |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf | |
| 04/29/2010 | SUPPL-4 |
REMS-Proposal |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf | |
| 07/29/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf |
COLCRYS
TABLET;ORAL; 0.6MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 211250 | ALKEM LABS LTD |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 204711 | AMNEAL PHARMS |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 209876 | DR REDDYS |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 210425 | GRANULES |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 209470 | MYLAN |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 204461 | WATSON LABS INC |
| COLCHICINE | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | No | AB | 211519 | ZYDUS PHARMS |
| COLCRYS | COLCHICINE | 0.6MG | TABLET;ORAL | Prescription | Yes | AB | 022352 | TAKEDA PHARMS USA |
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