01 1Aurobindo Pharma Limited
01 1FLUOXETINE HYDROCHLORIDE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-21
Pay. Date : 2019-06-14
DMF Number : 33940
Submission : 2019-06-15
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 FLUOXETINE HYDROCHLORIDE USP (PROCESS II), with a corresponding US DMF Number 33940.
Remarkably, this DMF maintains an Active status since its submission on June 15, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 21, 2019, and payment made on June 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
