01 1Roquette
01 1DEXTROSE MONOHYDRATE, USP GRADE
01 1France
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-23
Pay. Date : 2015-01-05
DMF Number : 11059
Submission : 1994-09-01
Status : Active
Type : II
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Roquette America Inc, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is DEXTROSE MONOHYDRATE, USP GRADE, with a corresponding US DMF Number 11059.
Remarkably, this DMF maintains an Active status since its submission on September 01, 1994, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 23, 2015, and payment made on January 05, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
