01 1Aurobindo Pharma Limited
01 1CITALOPRAM HYDROBROMIDE USP (ROUTE-1)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-13
Pay. Date : 2014-11-07
DMF Number : 19588
Submission : 2006-06-30
Status : Active
Type : II
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Apitoria Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is CITALOPRAM HYDROBROMIDE USP (ROUTE-1), with a corresponding US DMF Number 19588.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2014, and payment made on November 07, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
