Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077527
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG;0.03MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 05/09/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077527s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2024 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/09/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/09/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |