Article content

Supplemental New Drug Application

Supplemental New Drug Application, also called a sNDA, is an application submitted to the FDA for an already approved NDA for any changes in packaging, labeling, dosages, ingredients or new indications. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).

<< Back to Glossary Index