01 1Hetero Drugs
01 1ESCITALOPRAM OXALATE (PROCESS-I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-17
Pay. Date : 2013-03-07
DMF Number : 17960
Submission : 2004-12-29
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-I), with a corresponding US DMF Number 17960.
Remarkably, this DMF maintains an Active status since its submission on December 29, 2004, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2013, and payment made on March 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
