01 1Lunan Pharmaceutical
01 1DILUTED ISOSORBIDE DINITRATE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2024-01-31
DMF Number : 36099
Submission : 2021-12-05
Status : Active
Type : II
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Shandong New Time Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is DILUTED ISOSORBIDE DINITRATE USP, with a corresponding US DMF Number 36099.
Remarkably, this DMF maintains an Active status since its submission on December 05, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 12, 2024, and payment made on January 31, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
