01 1Alembic Pharmaceuticals Limited
01 1HYDROCHLOROTHIAZIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-09
DMF Number : 22253
Submission : 2008-11-29
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 HYDROCHLOROTHIAZIDE USP, with a corresponding US DMF Number 22253.
Remarkably, this DMF maintains an Active status since its submission on November 29, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 07, 2015, and payment made on April 09, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
