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List of Drug Master Files (DMF) for 28561 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Arevipharma (1)

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01 DIMETHYL FUMARATE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28561
Active
2014-10-16
Complete
2015-02-24
2014-10-22
II
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Looking for Drug Master Files (DMF) for 28561 of Arevipharma Gmbh

Looking for Drug Master Files (DMF) for 28561 of Arevipharma Gmbh 1

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Arevipharma Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIMETHYL FUMARATE, with a corresponding US DMF Number 28561.

Remarkably, this DMF maintains an Active status since its submission on October 16, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 24, 2015, and payment made on October 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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