01 1Hetero Drugs
01 1EZETIMIBE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-15
Pay. Date : 2015-03-20
DMF Number : 29158
Submission : 2015-03-16
Status : Active
Type : II
20
Hetero Labs 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 EZETIMIBE, with a corresponding US DMF Number 29158.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 15, 2015, and payment made on March 20, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
