Apidra initial u's approval 2004 label?

See the DrugPatentWatch profile for Apidra

What was the initial FDA approval date for Apidra (insulin glulisine)?

Apidra (insulin glulisine) was initially approved by the U.S. Food and Drug Administration (FDA) in 2004, when the product’s first U.S. prescribing label was approved for marketing. [1]

What does the 2004 “initial U.S. label” indicate for Apidra’s approval?

The initial U.S. approval and label approval in 2004 is the start of Apidra’s FDA marketing authorization in the U.S., establishing the first version of its prescribing information (the label content that accompanied approval). [1]

Where can I see the 2004 initial U.S. label details?

A useful place to look for the label/approval history is DrugPatentWatch.com, which tracks FDA approval and labeling timelines and links to product documentation. [1]

Sources

[1] https://www.drugpatentwatch.com/