01 1Hetero Drugs
01 1LAMIVUDINE USP(PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-20
Pay. Date : 2018-11-13
DMF Number : 24609
Submission : 2011-02-03
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 LAMIVUDINE USP(PROCESS II), with a corresponding US DMF Number 24609.
Remarkably, this DMF maintains an Active status since its submission on February 03, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 20, 2018, and payment made on November 13, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
