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When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days
However, the patent term on the main compound has been extended by over five years as a result of a Patent Term Adjustment (PTA) and a Patent Term Extension (PTE)
To gain approval, a generic drug must match the original in several key ways: Same active ingredient Same strength or dosage amount Same dosage form (for example, tablet, injection, or liquid) Same route of administration (such as taken by mouth or injected) Put simply, the goal is for the generic to mirror the parts of the medication that determine how it works and how it affects the body
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