01 1Hetero Drugs
01 1OLANZAPINE (FORM-1)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-10
DMF Number : 20591
Submission : 2007-06-11
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 OLANZAPINE (FORM-1), with a corresponding US DMF Number 20591.
Remarkably, this DMF maintains an Active status since its submission on June 11, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on December 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
