Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077021
Company: CASI PHARMS INC
Company: CASI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77021ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/01/2017 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/10/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |