01 1Alembic Pharmaceuticals Limited
01 1FLUOXETINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-05-02
DMF Number : 25778
Submission : 2012-02-27
Status : Active
Type : II
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Alembic Pharmaceuticals 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, with a corresponding US DMF Number 25778.
Remarkably, this DMF maintains an Active status since its submission on February 27, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 13, 2013, and payment made on May 02, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
