Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022042
Company: LILLY
Company: LILLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EVISTA | RALOXIFENE HYDROCHLORIDE | 60MG | 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 |
---|---|---|---|---|---|---|---|
09/13/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022042_evista_toc.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/13/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf |