01 1Hetero Drugs
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 : 34223
Submission : 2019-10-30
Status : Active
Type : II
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Hetero Drugs 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 34223.
Remarkably, this DMF maintains an Active status since its submission on October 30, 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
