01 1Zydus Lifesciences
01 1DULOXETINE HYDROCHLORIDE USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-26
Pay. Date : 2014-06-26
DMF Number : 28390
Submission : 2014-06-30
Status : Active
Type : II
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Zydus Lifesciences 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 USP (PROCESS-II), with a corresponding US DMF Number 28390.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 26, 2014, and payment made on June 26, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
