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Athena Athena

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List of Drug Master Files (DMF) for 21841 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Curia (1)

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01 HYDROCORTISONE BUTYRATE, MICRONIZED (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
21841
Active
2008-07-31
Complete
2013-01-09
2012-12-17
II
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Looking for Drug Master Files (DMF) for 21841 of Curia Spain Sau

Looking for Drug Master Files (DMF) for 21841 of Curia Spain Sau 1

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Curia Spain Sau, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

One of their notable products is HYDROCORTISONE BUTYRATE, MICRONIZED, with a corresponding US DMF Number 21841.

Remarkably, this DMF maintains an Active status since its submission on July 31, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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