01 1Srikem Laboratories Pvt. Ltd
01 1HYDROXYZINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-07-11
DMF Number : 28376
Submission : 2014-06-06
Status : Active
Type : II
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Srikem Laboratories Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is HYDROXYZINE HYDROCHLORIDE USP, with a corresponding US DMF Number 28376.
Remarkably, this DMF maintains an Active status since its submission on June 06, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2015, and payment made on July 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
