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List of Drug Master Files (DMF) for 7600 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 DILTIAZEM HYDROCHLORIDE (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
7600
Active
1988-07-18
Complete
2013-01-18
2012-12-12
II
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Looking for Drug Master Files (DMF) for 7600 of Fis Fabbrica Italiana Sintetici Spa

Looking for Drug Master Files (DMF) for 7600 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 DILTIAZEM HYDROCHLORIDE, with a corresponding US DMF Number 7600.

Remarkably, this DMF maintains an Active status since its submission on July 18, 1988, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 12, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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