01 1Antibiotice
01 1NYSTATIN
01 1Romania
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-21
DMF Number : 14813
Submission : 2000-03-31
Status : Active
Type : II
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Antibiotice Sa, based in Romania, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is NYSTATIN, with a corresponding US DMF Number 14813.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
