01 1Alkaloida Chemical Company Zrt
01 1PHENOBARBITAL SODIUM, USP
01 1Hungary
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-31
Pay. Date : 2020-03-06
DMF Number : 34598
Submission : 2020-03-10
Status : Active
Type : II
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Alkaloida Chemical Co Zrt, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PHENOBARBITAL SODIUM, USP, with a corresponding US DMF Number 34598.
Remarkably, this DMF maintains an Active status since its submission on March 10, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2020, and payment made on March 06, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
