01 1Amsa
01 1GLYCOPYRROLATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-13
Pay. Date : 2015-03-06
DMF Number : 16972
Submission : 2003-11-13
Status : Active
Type : II
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Amsa Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is GLYCOPYRROLATE, with a corresponding US DMF Number 16972.
Remarkably, this DMF maintains an Active status since its submission on November 13, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 13, 2015, and payment made on March 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
