01 1Hetero Drugs
01 1LAPATINIB DITOSYLATE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-21
Pay. Date : 2021-09-09
DMF Number : 27602
Submission : 2013-10-01
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 LAPATINIB DITOSYLATE MONOHYDRATE, with a corresponding US DMF Number 27602.
Remarkably, this DMF maintains an Active status since its submission on October 01, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 21, 2021, and payment made on September 09, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
