Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013718
Company: GEMINI LABS LLC
Company: GEMINI LABS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXANDRIN | OXANDROLONE | 2.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| OXANDRIN | OXANDROLONE | 10MG | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/20/2005 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf | |
| 04/21/2003 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13718slr022_Oxandrin_lbl.pdf | |
| 11/05/2001 | SUPPL-21 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf | |
| 11/05/2001 | SUPPL-20 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf |