01 1Laurus Labs
01 1MONTELUKAST SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-24
Pay. Date : 2017-03-13
DMF Number : 23736
Submission : 2010-04-16
Status : Active
Type : II
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Laurus Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is MONTELUKAST SODIUM USP, with a corresponding US DMF Number 23736.
Remarkably, this DMF maintains an Active status since its submission on April 16, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 24, 2017, and payment made on March 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
