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01 1Fresenius Kabi Austria

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PharmaCompass

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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2017-02-22

Pay. Date : 2017-01-23

DMF Number : 20562

Submission : 2007-05-29

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 20562 of Fresenius Kabi Austria Gmbh

Looking for Drug Master Files (DMF) for 20562 of Fresenius Kabi Austria Gmbh 1

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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 CONCENTRATE USP, with a corresponding US DMF Number 20562.

Remarkably, this DMF maintains an Active status since its submission on May 29, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 22, 2017, and payment made on January 23, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II