01 1Zydus Lifesciences
01 1TIZANIDINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-30
DMF Number : 34929
Submission : 2020-06-23
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 TIZANIDINE HYDROCHLORIDE USP, with a corresponding US DMF Number 34929.
Remarkably, this DMF maintains an Active status since its submission on June 23, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 12, 2020, and payment made on September 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
