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(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

Due to their potential danger, aviation authorities worldwide have banned them to ensure passenger safety

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