01 1Zydus Lifesciences
01 1TOPIRAMATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-12-06
DMF Number : 18700
Submission : 2005-08-25
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 TOPIRAMATE USP, with a corresponding US DMF Number 18700.
Remarkably, this DMF maintains an Active status since its submission on August 25, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2014, and payment made on December 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
