01 1Lunan Pharmaceutical
01 1DILUTED ISOSORBIDE MONONITRATE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-22
Pay. Date : 2018-11-26
DMF Number : 29555
Submission : 2015-07-17
Status : Active
Type : II
20
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 USP, with a corresponding US DMF Number 29555.
Remarkably, this DMF maintains an Active status since its submission on July 17, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2019, and payment made on November 26, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
