Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022045
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

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