01 1Hetero Drugs
01 1DULOXETINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-09-23
DMF Number : 25280
Submission : 2011-09-12
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 DULOXETINE HYDROCHLORIDE, with a corresponding US DMF Number 25280.
Remarkably, this DMF maintains an Active status since its submission on September 12, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
