01 1Procos
01 1PROPAFENONE HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 11426
Submission : 1995-04-03
Status : Active
Type : II
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Procos Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is PROPAFENONE HYDROCHLORIDE, with a corresponding US DMF Number 11426.
Remarkably, this DMF maintains an Active status since its submission on April 03, 1995, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2013, and payment made on June 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
