01 1Cambrex Corporation
01 1ONDANSETRON HCL
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-23
Pay. Date : 2018-09-13
DMF Number : 15752
Submission : 2001-12-05
Status : Active
Type : II
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Cambrex Charles City Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Cambrex is an innovative life sciences company with a refreshingly human approach.
One of their notable products is ONDANSETRON HCL, with a corresponding US DMF Number 15752.
Remarkably, this DMF maintains an Active status since its submission on December 05, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 23, 2018, and payment made on September 13, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
