Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms
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The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000037) entitled "Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the- Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms." This proposed order, if finalized, will require over-the- counter (OTC) monograph drugs in an orally disintegrating tablet (ODT) or film dosage form that are subject to specified OTC monographs to be packaged in single-unit or unit-dose containers.
Abstract as published in the Federal Register.
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