Drugs@FDA: FDA-Approved Drugs
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-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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03/09/2012 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
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. |
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06/27/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/07/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
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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 | 077722 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077831 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077022 | EPIC PHARMA LLC |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE RUN PHARMA |
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 | 077831 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077022 | EPIC PHARMA LLC |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE RUN PHARMA |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077027 | TEVA |