01 1Sifavitor srl
01 1LABETALOL HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-16
Pay. Date : 2019-03-15
DMF Number : 11779
Submission : 1995-12-22
Status : Active
Type : II
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Olon Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is LABETALOL HYDROCHLORIDE, with a corresponding US DMF Number 11779.
Remarkably, this DMF maintains an Active status since its submission on December 22, 1995, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2019, and payment made on March 15, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
