FDA regulatory

OTC monograph

Definition

A rulebook that lets an over-the-counter drug be marketed without individual approval, provided it conforms to the monograph.

Monograph products still require listing and an NDC, which is why store-brand painkillers and antacids appear in FDA data with no application number.

Marketing categoryThe FDA field stating the legal basis on which a product is marketed — NDA, ANDA, BLA, OTC monograph and others.Definition Private label distributorA retailer or wholesaler whose store-brand drugs carry its own labeler code.Definition

More in FDA regulatory

505(b)(2)AB rating Abbreviated New Drug Application (ANDA)Active ingredient Active moiety Biologics License Application (BLA)Biosimilar Boxed warning

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