01 1Gedeon Richter
01 1AZELASTINE HCL USP
01 1Hungary
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2015-02-18
DMF Number : 15361
Submission : 2001-03-29
Status : Active
Type : II
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Gedeon Richter Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is AZELASTINE HCL USP, with a corresponding US DMF Number 15361.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2015, and payment made on February 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
