01 1Unichem Laboratories Limited
01 1ZOLPIDEM TARTRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-25
Pay. Date : 2015-09-04
DMF Number : 21193
Submission : 2007-12-28
Status : Active
Type : II
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Unichem Laboratories 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 ZOLPIDEM TARTRATE USP, with a corresponding US DMF Number 21193.
Remarkably, this DMF maintains an Active status since its submission on December 28, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2016, and payment made on September 04, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
