|2005D-0312|| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability|
|FDA Comment Number :||EC2|
|Submitter :||Ms. Jenny Peters||Date & Time:||12/09/2005 10:12:37|
|Category :||Drug Industry|
| Line 35 - Addition of the following statement: Impurities arising from excipients present in the drug product or extracted or leached
from the container closure system are not covered by this guidance document.