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Bio-T-Gel Approval History

  • FDA approved: Yes (First approved February 14th, 2012)
  • Brand name: Bio-T-Gel
  • Generic name: testosterone
  • Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
  • Treatment for: Hypogonadism, Male

Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.

Development History and FDA Approval Process for Bio-T-Gel

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

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