01 1Recordati
01 1KETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENT
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-21
DMF Number : 20728
Submission : 2007-07-26
Status : Active
Type : II
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Recordati Industria Chimica E Farmaceutica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is KETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENT, with a corresponding US DMF Number 20728.
Remarkably, this DMF maintains an Active status since its submission on July 26, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2013, and payment made on November 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
