01 1Lunan Pharmaceutical
01 1DILUTED ISOSORBIDE MONONITRATE (60%)
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-12-24
DMF Number : 23216
Submission : 2009-10-21
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 MONONITRATE (60%), with a corresponding US DMF Number 23216.
Remarkably, this DMF maintains an Active status since its submission on October 21, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2014, and payment made on December 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
