Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076761
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXANDROLONE | OXANDROLONE | 2.5MG | 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 |
---|---|---|---|---|---|---|---|
12/01/2006 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076761lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076761ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076761_XANDROLONE_TABS_ORIGINAL_AP.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2015 | SUPPL-7 | 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 |
---|---|---|---|---|---|
12/01/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/076761lbl.pdf |