SIP Approved Drug

**Semantic type:** Manufactured Object

**Definition:** An FDA-approved prescription drug or combination product that has been approved by, received a Notice of Compliance from, and received a Drug Identification Number (DIN) from the Health Products and Food Branch of Health Canada (HPFB). But for the fact that it deviates from the required U.S. labeling, it is approved in an ANDA, or NDA, is originally authorized for marketing in a foreign country, and imported for marketing in the U.S. under Section 804 Importation Program (SIP) Rule of the Federal Food Drug, and Cosmetic Act.

**Synonyms:** - Section 804 Importation Program Approved Drug