01 1Biocon
01 1DASATINIB MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-16
Pay. Date : 2021-09-17
DMF Number : 36185
Submission : 2021-09-30
Status : Active
Type : II
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Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is DASATINIB MONOHYDRATE, with a corresponding US DMF Number 36185.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2021, and payment made on September 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
