01 1Recordati
01 1PHENYTOIN SODIUM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-18
Pay. Date : 2024-10-15
DMF Number : 4538
Submission : 1982-04-07
Status : Active
Type : II
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Recordati Industria Chimica E Farmaceutica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PHENYTOIN SODIUM, with a corresponding US DMF Number 4538.
Remarkably, this DMF maintains an Active status since its submission on April 07, 1982, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2024, and payment made on October 15, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
