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List of Drug Master Files (DMF) for 17395 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

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01 FLUOCINOLONE ACETONIDE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

17395
Active
2004-05-19
Complete
2013-05-16
2013-05-07
II
Axplora CB

Cophex 2024

Not Confirmed

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Looking for Drug Master Files (DMF) for 17395 of Farmabios Spa

Looking for Drug Master Files (DMF) for 17395 of Farmabios Spa 1

20

Farmabios Spa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Axplora- The partner of choice for complex APIs.

One of their notable products is FLUOCINOLONE ACETONIDE, with a corresponding US DMF Number 17395.

Remarkably, this DMF maintains an Active status since its submission on May 19, 2004, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2013, and payment made on May 07, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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