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NDA 201532 Page 3 of 16 Vial Label: 1. Change “Tradename” to Halaven 2. The established name should be “(eribulin mesylate) injection” 3. Revise the statement of strength to read: 1 mg/2 mL (0.5 mg/mL) 4. Reloe the statement of strength to the line below
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6 Chapter 15-Inspection,Labeling,and Packaging Figure 15-1. Pharmaceutical manual inspection booth (courtesy OEM-Optical) The amount of time each container or set of containers is inspected should be limited and defined within the inspection Standard
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ü Use clear tape to protect label ü Label without obstruc2ng view of sample contents ü Place label evenly ü Choose a label suited for storage condi2ons (e.g. labels with special adhesive for temperatures at -70 C) x Write directly onto container with marker or wax pencil x Write
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