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
CILOSTAZOL از شرکت HIKMA
Abbreviated New Drug Application (ANDA): 077024
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CILOSTAZOL | CILOSTAZOL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/2005 | 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 |
|---|---|---|---|---|---|
| 03/25/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/09/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/09/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
CILOSTAZOL
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077030 | APOTEX INC |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077310 | CASI PHARMS INC |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077722 | CHARTWELL RX |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077831 | CHARTWELL RX |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077024 | HIKMA |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE |
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077027 | TEVA |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077030 | APOTEX INC |
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077021 | CASI PHARMS INC |
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077831 | CHARTWELL RX |
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077024 | HIKMA |
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE |
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077027 | TEVA |
منبع : www.accessdata.fda.gov
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