01 1Fresenius Kabi Austria
01 1LACTULOSE CRYSTALS
01 1Austria
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2012-11-28
DMF Number : 15254
Submission : 2001-02-16
Status : Active
Type : II
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Fresenius Kabi Austria Gmbh, based in Austria, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is LACTULOSE CRYSTALS, with a corresponding US DMF Number 15254.
Remarkably, this DMF maintains an Active status since its submission on February 16, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 25, 2013, and payment made on November 28, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
