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01 1Katwijk Chemie

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GDUFA

DMF Review : Complete

Rev. Date : 2015-05-26

Pay. Date : 2014-12-29

DMF Number : 11308

Submission : 1995-01-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 11308 of Katwijk Chemie Bv

Looking for Drug Master Files (DMF) for 11308 of Katwijk Chemie Bv 1

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Katwijk Chemie Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is OXAPROZIN, with a corresponding US DMF Number 11308.

Remarkably, this DMF maintains an Active status since its submission on January 18, 1995, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2015, and payment made on December 29, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II