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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

DateArticle
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

Further information

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