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List of Drug Master Files (DMF) for 23031 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ALP Pharm (1)

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01 BROENAC SODIUM HYDRATE (1)

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01 China (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
23031
Active
2009-07-31
Complete
2013-05-01
2013-04-16
II
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Looking for Drug Master Files (DMF) for 23031 of Alp Pharm Beijing Co Ltd

Looking for Drug Master Files (DMF) for 23031 of Alp Pharm Beijing Co Ltd 1

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Alp Pharm Beijing Co Ltd, based in China, is a pharmaceutical company.

One of their notable products is BROENAC SODIUM HYDRATE, with a corresponding US DMF Number 23031.

Remarkably, this DMF maintains an Active status since its submission on July 31, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 01, 2013, and payment made on April 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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