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Testosterone Cypionate Injection, USP CIII Overview Presentation(s): 1,000 mg/10 mL 200 mg/mL 2,000 mg/10 mL NDC(s): 55150-276-01 55150-277-01 55150-278-01 Reference Listed Drug: Depo-Testosterone Therapeutic Class: Androgens Physical Form: Solution Product Information Wholesaler Item Numbers ABC 10285387 Cardinal 5885504 McKesson 2880383 M&D 323980 Ordering Information Unit of Sale 1 Pack Size 1 Case Quantity 48 Allergens Wholesaler Item Numbers ABC 10285429 Cardinal 5885512 McKesson 2880391 M&D 323998 Ordering Information Unit of Sale 1 Pack Size 1 Case Quantity 48 Allergens Wholesaler Item Numbers ABC 10285416 Cardinal 5885520 McKesson 2880425 M&D 324046 Ordering Information Unit of Sale 1 Pack Size 1 Case Quantity 48 Allergens Additional Information Bioequivalency Rating AO Bar Code Type Linear Controlled Substance Class C-III Storage Requirements: Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]

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There was overlap of the trial population with the reimbursement criteria requested by the sponsor for the resubmission patients with a BMI of 27 kg/m 2 or greater and established CVD (MI, stroke, and/or PAD)

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