Fresenius Kabi Pharmaceuticals (APCVZ)

[saa63]

Here is the link to the drug pdf from the fda website.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf

Here is a link to the approval page

http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=022536&DrugName=INDOMETHACIN&ActiveIngred=INDOMETHACIN&SponsorApplicant=APP%20PHARMS&ProductMktStatus=1

In laymens terms the drug does this: Before birth there is an opening in the heart from the left side to the right side that should close when we take our first breath. If it doesn't close it could lead to cardiac failure (aka death). This drug contains a chemical that makes the hole close up. This condition is only in babies.