01 1Lunan Pharmaceutical
01 1MONTELUKAST SODIUM USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-21
Pay. Date : 2021-07-06
DMF Number : 33973
Submission : 2019-08-13
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 MONTELUKAST SODIUM USP, with a corresponding US DMF Number 33973.
Remarkably, this DMF maintains an Active status since its submission on August 13, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 21, 2021, and payment made on July 06, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
