01 1Hetero Drugs
01 1LAMIVUDINE, USP (FORM I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 24947
Submission : 2011-05-18
Status : Active
Type : II
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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 (FORM I), with a corresponding US DMF Number 24947.
Remarkably, this DMF maintains an Active status since its submission on May 18, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2013, and payment made on August 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
