01 1Zhejiang Apeloa Jiayuan Pharmaceutical
01 1METAXALONE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-08-01
DMF Number : 25533
Submission : 2011-11-21
Status : Active
Type : II
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Zhejiang Apeloa Jiayuan Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is METAXALONE, with a corresponding US DMF Number 25533.
Remarkably, this DMF maintains an Active status since its submission on November 21, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2013, and payment made on August 01, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
