01 1Olon S.p.A
01 1LOPERAMIDE HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2013-08-07
DMF Number : 10028
Submission : 1992-12-30
Status : Active
Type : II
20
Olon Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is LOPERAMIDE HYDROCHLORIDE, with a corresponding US DMF Number 10028.
Remarkably, this DMF maintains an Active status since its submission on December 30, 1992, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2014, and payment made on August 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
