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Athena Athena

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List of Drug Master Files (DMF) for 467 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 F.I.S. Fabbrica Italiana Sintetici (1)

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01 CHLORDIAZEPOXIDE HCL (1)

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01 Italy (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
467
Active
1962-02-15
Complete
2017-11-16
2017-10-26
II
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Looking for Drug Master Files (DMF) for 467 of Fis Fabbrica Italiana Sintetici Spa

Looking for Drug Master Files (DMF) for 467 of Fis Fabbrica Italiana Sintetici Spa 1

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Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is CHLORDIAZEPOXIDE HCL, with a corresponding US DMF Number 467.

Remarkably, this DMF maintains an Active status since its submission on February 15, 1962, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2017, and payment made on October 26, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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