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GDUFA

DMF Review : Complete

Rev. Date : 2022-10-18

Pay. Date : 2022-07-14

DMF Number : 37079

Submission : 2022-07-15

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 37079 of Lee Pharma Ltd

Looking for Drug Master Files (DMF) for 37079 of Lee Pharma Ltd 1

20

Lee Pharma Ltd, based in India, is a pharmaceutical company.

One of their notable products is METAXALONE USP, with a corresponding US DMF Number 37079.

Remarkably, this DMF maintains an Active status since its submission on July 15, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2022, and payment made on July 14, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II