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This civil money penalty is not affected if the manufacturer pays the rebate amount once it is past the deadline, nor is it impacted by the reconciled rebate amount, because at the payment deadline missed by the manufacturer, the manufacturer owed a rebate of $100 to CMS and that rebate amount was not paid timely
(2) A generic drug approved under an Abbreviated New Drug Application ( (ANDA) under section 505(j) of the FD&C Act (section 505(j) ANDA), in the case where: (i) The reference listed drug approved under an NDA under section 505(c) of the FD&C Act, including any authorized generic drug as defined in section 505(t)(3) of the FD&C Act, is not being marketed, as identified in the Food and Drug Administration's (FDA) NDC Directory
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