OTC Drug Monograph
OTC drugs are defined as "drugs that are safe and effective for use by the general public without seeking treatment by a health professional."
OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval.
New FDA OTC Monograph Drug Facility Fees 2023
Examples of Drugs in FDA Monograph
These are not complete list of products in FDA OTC drug monograph. The status of drug in OTC monograph may change please contact FDA for updated information.Back to previous page
|FDA Registration, US Agent, Labeler code||USD 649 (Annually)|
|Drug listing||USD 399 / Drug|
|Label Review||USD 649 / Drug|
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