A supplement number is associated with an existing FDA New Drug Application (NDA) number. 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). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.
- Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval