MRC | Criteria | Characteristic |
---|---|---|
AGXW | PHYSICAL FORM | FREEZE-DRIED POWDER |
CRLK | PRIMARY CONTAINER CONTENT QUANTITY | 1000.000 INTERNATIONAL UNITS OF ACTIVE INGREDIENT |
CXCY | PART NAME ASSIGNED BY CONTROLLING AGENCY | ANTIHEMOPHILIC FACTOR USP LYOPHILIZED FORM FACTOR VIII:C HUMAN |
FEAT | SPECIAL FEATURES | FACTOR VIII:C HUMAN;HEAT TREATED,AND/OR SOLUTION/DETERGENT CONCENTRATE;EACH VIAL PACKAGED W/SUFFICIENT DILUENT,STERILE FILTER NEEDLE AND ONE WINGED INFUSION SET;1 VIAL |
CQCT | PRIMARY CONTAINER TYPE | VIAL, SINGLE DOSE |
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