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.

FDA Approval History for Bio-T-Gel

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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