Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078515
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;0.02MG | 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 |
---|---|---|---|---|---|---|---|
03/30/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/078515Orig1s000correctedltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/06/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
10/06/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
07/02/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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07/02/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078515s000lbl.pdf |