01 1Helsinn Advanced Synthesis
01 1ISOTRETINOIN
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2012-12-14
DMF Number : 19918
Submission : 2006-10-30
Status : Active
Type : II
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Has Healthcare Advanced Synthesis Sa, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ISOTRETINOIN, with a corresponding US DMF Number 19918.
Remarkably, this DMF maintains an Active status since its submission on October 30, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2013, and payment made on December 14, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
