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Testosterone Gel Approval History

  • FDA approved: Yes (First approved February 14th, 2012)
  • Brand name: Testosterone Gel
  • Generic name: testosterone
  • Dosage form: Topical Gel
  • Previous name: Bio-T-Gel
  • Company: ANI Pharmaceuticals, Inc.
  • Treatment for: Hypogonadism, Male

Testosterone Gel is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.

Development History and FDA Approval Process for Testosterone Gel

Feb 15, 2012Approval BioSante Pharmaceuticals Announces FDA Approval for Male Testosterone Gel
Apr 13, 2011BioSante Pharmaceuticals Announces Teva New Drug Application for Bio-T-Gel

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