01 1Hetero Drugs
01 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-03
Pay. Date : 2013-02-19
DMF Number : 25686
Submission : 2012-01-09
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 IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B), with a corresponding US DMF Number 25686.
Remarkably, this DMF maintains an Active status since its submission on January 09, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 03, 2015, and payment made on February 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
