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
CAPECITABINE از شرکت TEVA PHARMS USA
Abbreviated New Drug Application (ANDA): 091649
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription |
AB |
No | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2013 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091649Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/17/2019 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/17/2019 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/16/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091649Orig1s000lbl.pdf |
CAPECITABINE
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 202593 | ACCORD HLTHCARE |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 207652 | ALKEM LABS LTD |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 204741 | AMNEAL PHARMS |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 204345 | DR REDDYS LABS LTD |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 210604 | EUGIA PHARMA |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 200483 | HIKMA PHARMS |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 209365 | MSN |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090943 | MYLAN |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 211724 | RELIANCE LIFE |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 207456 | SHILPA |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 204668 | SUN PHARM |
| CAPECITABINE | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | No | AB | 091649 | TEVA PHARMS USA |
| XELODA | CAPECITABINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020896 | HOFFMANN LA ROCHE |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 202593 | ACCORD HLTHCARE |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 207652 | ALKEM LABS LTD |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 204741 | AMNEAL PHARMS |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 204345 | DR REDDYS LABS LTD |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 210604 | EUGIA PHARMA |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 200483 | HIKMA PHARMS |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 209365 | MSN |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 090943 | MYLAN |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 211724 | RELIANCE LIFE |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 207456 | SHILPA |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 204668 | SUN PHARM |
| CAPECITABINE | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | No | AB | 091649 | TEVA PHARMS USA |
| XELODA | CAPECITABINE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 020896 | HOFFMANN LA ROCHE |
حتما بخوانید : CAPECITABINE از شرکت HIKMA PHARMS
منبع : www.accessdata.fda.gov
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