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 TEVA
Abbreviated New Drug Application (ANDA): 077027
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription |
AB |
No | Yes |
| CILOSTAZOL | CILOSTAZOL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/24/2004 | 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 |
|---|---|---|---|---|---|
| 12/18/2020 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/09/2012 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/31/2014 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/27/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/07/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/08/2006 | SUPPL-2 | 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
نظرات کاربران