01 1BIOTIKA a.s.
01 1POLYMYXIN B SULFATE
01 1Slovakia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2013-12-11
DMF Number : 23876
Submission : 2010-05-31
Status : Active
Type : II
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Biotika As, based in Slovakia, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is POLYMYXIN B SULFATE, with a corresponding US DMF Number 23876.
Remarkably, this DMF maintains an Active status since its submission on May 31, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2014, and payment made on December 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
