01 1Macleods Pharmaceuticals Limited
01 1VARENICLINE TARTRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-26
Pay. Date : 2019-10-23
DMF Number : 34096
Submission : 2019-09-27
Status : Active
Type : II
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Macleods Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is VARENICLINE TARTRATE, with a corresponding US DMF Number 34096.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 26, 2019, and payment made on October 23, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
