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
BISOPROLOL FUMARATE از شرکت UNICHEM
Abbreviated New Drug Application (ANDA): 078635
Company: UNICHEM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription |
AB |
No | No |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription |
AB |
No | 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 |
---|---|---|---|---|---|---|---|
08/18/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/07/2019 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/19/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/26/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BISOPROLOL FUMARATE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 204891 | ALEMBIC LABS |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077910 | AUROBINDO PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075474 | FRONTIDA BIOPHARM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215563 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075643 | RUBICON |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 5MG | TABLET;ORAL | Prescription | No | AB | 078635 | UNICHEM |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 204891 | ALEMBIC LABS |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077910 | AUROBINDO PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075474 | FRONTIDA BIOPHARM |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 215563 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075643 | RUBICON |
BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | 10MG | TABLET;ORAL | Prescription | No | AB | 078635 | UNICHEM |
حتما بخوانید : BISOPROLOL FUMARATE از شرکت ALEMBIC LABS
منبع : www.accessdata.fda.gov
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