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List of Drug Master Files (DMF) for 14693 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 TRIAMCINOLONE ACETONIDE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

14693
Active
2000-02-01
Complete
2013-05-21
2013-05-14
II
Axplora CB

Cophex 2024

Not Confirmed

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Looking for Drug Master Files (DMF) for 14693 of Farmabios Spa

Looking for Drug Master Files (DMF) for 14693 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 TRIAMCINOLONE ACETONIDE, with a corresponding US DMF Number 14693.

Remarkably, this DMF maintains an Active status since its submission on February 01, 2000, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 21, 2013, and payment made on May 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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