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List of Drug Master Files (DMF) for 23860 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Zydus Lifesciences (1)

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01 BENZOYL PEROXIDE HYDROUS USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
23860
Active
2010-06-04
Complete
2016-07-19
2016-06-13
II
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Looking for Drug Master Files (DMF) for 23860 of Zydus Lifesciences Ltd

Looking for Drug Master Files (DMF) for 23860 of Zydus Lifesciences Ltd 1

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Zydus Lifesciences 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 BENZOYL PEROXIDE HYDROUS USP, with a corresponding US DMF Number 23860.

Remarkably, this DMF maintains an Active status since its submission on June 04, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 19, 2016, and payment made on June 13, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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