01 1Zhejiang Lepu Pharmaceutical
01 1AZELASTINE HYDROCHLORIDE, USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-09
Pay. Date : 2025-05-29
DMF Number : 36748
Submission : 2022-03-16
Status : Active
Type : II
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Zhejiang Lepu Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is AZELASTINE HYDROCHLORIDE, USP, with a corresponding US DMF Number 36748.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2025, and payment made on May 29, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
