Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077019
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| 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/2004/77019LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/10/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/03/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |