01 1Norac Pharma
01 1HYDROUS BENZOYL PEROXIDE, USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-15
Pay. Date : 2014-04-11
DMF Number : 15748
Submission : 2001-12-03
Status : Active
Type : II
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Alkem Laboratories Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is HYDROUS BENZOYL PEROXIDE, USP, with a corresponding US DMF Number 15748.
Remarkably, this DMF maintains an Active status since its submission on December 03, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 15, 2015, and payment made on April 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
