Apidra label initial u.s. approval 2004?

What was Apidra’s initial FDA approval date (U.S.)?

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

Where can I verify the exact approval date on FDA records?

The most reliable place to confirm the exact “initial approval” month/day for Apidra is the FDA’s drug labeling/approval history (for example, the FDA labeling database entries that list the “Initial U.S. Approval” year and related review information).

Why does this show up as only a year sometimes?

Many commonly cited references (including drug label summaries and databases) report “Initial U.S. Approval: 2004” rather than the full date, so the underlying FDA label/approval record is needed if you need the specific day.

Sources

1. DailyMed – APIDRA (insulin glulisine) label (Initial U.S. Approval: 2004)