01 1Unichem Laboratories Limited
01 1PHENYTOIN SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-03-27
DMF Number : 32676
Submission : 2018-03-29
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 PHENYTOIN SODIUM USP, with a corresponding US DMF Number 32676.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 31, 2018, and payment made on March 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
