01 1Medilux Laboratories
01 1BACLOFEN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-27
Pay. Date : 2022-08-19
DMF Number : 35654
Submission : 2021-02-25
Status : Active
Type : II
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Medilux Laboratories Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is BACLOFEN, with a corresponding US DMF Number 35654.
Remarkably, this DMF maintains an Active status since its submission on February 25, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 27, 2022, and payment made on August 19, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
