01 1Esteve Quimica
01 1AZELASTINE HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2013-11-14
DMF Number : 22427
Submission : 2009-01-20
Status : Active
Type : II
20
Esteve Quimica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is AZELASTINE HYDROCHLORIDE, with a corresponding US DMF Number 22427.
Remarkably, this DMF maintains an Active status since its submission on January 20, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 20, 2013, and payment made on November 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
