Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022045
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YAZ | DROSPIRENONE; ETHINYL ESTRADIOL | 3MG; 0.02MG | TABLET; ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022045s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022045s000TOC.cfm |