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 SUN PHARM
Abbreviated New Drug Application (ANDA): 204668
Company: SUN PHARM
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 |
---|---|---|---|---|---|---|---|
06/21/2019 | ORIG-1 | Approval |
|
Label is not available on this site. |
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 |
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