01 1Lusochimica
01 1NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE)
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-09
DMF Number : 21625
Submission : 2008-03-25
Status : Active
Type : II
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Lusochimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE), with a corresponding US DMF Number 21625.
Remarkably, this DMF maintains an Active status since its submission on March 25, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 31, 2013, and payment made on January 09, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
