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Laboratory Quality Manufactured under strict quality control standards to support research material consistency, compound identity, analytical confidence, and qualified laboratory investigation
AOD-9604 FDA Approval History At a glance FDA approval status / Never approved for any indication in the United States NDA filing history / No New Drug Application has ever been submitted to FDA Chemical identity / Synthetic peptide corresponding to amino acids 176-191 of human growth hormone, with a tyrosine residue added at the C-terminus Developer / Metabolic Pharmaceuticals Ltd (Melbourne, Australia), now defunct Clinical trial outcome / Phase IIb trial (2007) failed to meet primary efficacy endpoint for obesity FDA compounding status / Placed on Category 2 list
Passed: Verifies the batch meets USP standards for microbial contamination
A 150 mcg dose = 0.045 mL = about 45 units on a U-100 syringe
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