Apidra initial u.s. approval 2004 label?

When did Apidra get its initial FDA approval in the U.S.?

Apidra (insulin glulisine) received its initial U.S. approval in 2004. [1]

What does the 2004 “initial approval” mean on the label?

On FDA labeling, “initial U.S. approval” refers to the first year the product was approved for marketing in the United States, before later label revisions or supplemental approvals. For Apidra, that initial approval year is listed as 2004. [1]

Where can I find “initial U.S. approval 2004” on the label?

The “initial U.S. approval” year appears in the prescribing information/labeling for Apidra, typically near the product identification details (such as the drug name/labeling header information). [1]

Sources

1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021629