01 1Hetero Drugs
01 1ESCITALOPRAM OXALATE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-10
Pay. Date : 2014-03-06
DMF Number : 26185
Submission : 2012-06-28
Status : Active
Type : II
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Hetero Labs 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 ESCITALOPRAM OXALATE (PROCESS II), with a corresponding US DMF Number 26185.
Remarkably, this DMF maintains an Active status since its submission on June 28, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 10, 2014, and payment made on March 06, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
