Testosterone Gel Approval History
FDA Approved: Yes (First approved February 14, 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, 2012||BioSante Pharmaceuticals Announces FDA Approval for Male Testosterone Gel|
|Apr 13, 2011||BioSante Pharmaceuticals Announces Teva New Drug Application for Bio-T-Gel|
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