01 1Clariant
01 1MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF)
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-15
Pay. Date : 2025-09-10
DMF Number : 13091
Submission : 1998-07-23
Status : Active
Type : II
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Clariant Produkte (deutschland) Gmbh, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF), with a corresponding US DMF Number 13091.
Remarkably, this DMF maintains an Active status since its submission on July 23, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 15, 2025, and payment made on September 10, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
