Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013718
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/21/1964 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013718s023ltr.pdf
04/21/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13718slr022_Oxandrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13718slr022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/013718_S022_Oxandrin Tabs_APPROVAL PACKAGE.pdf
11/05/2001 SUPPL-21 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf
11/05/2001 SUPPL-20 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/13718s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13718s20s21ltr.pdf
08/23/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1997 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1991 SUPPL-13 Labeling

Label is not available on this site.

02/24/1987 SUPPL-12 Labeling

Label is not available on this site.

11/30/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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

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