Search for IIG Limit (Inactive Ingredient Guideline)
Ingredient Name Route Dosage Form Potency Unit CAS Number UNII Record Updated
Inactive Ingredient Database

According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products are in this database.

The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.

Reference

https://www.fda.gov/Drugs/InformationOnDrugs/ucm080123.htm

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