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List of Drug Master Files (DMF) for 14093 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 DISHMAN NETHERLANDS B.V. (1)

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01 CALCITRIOL (1)

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01 Netherlands (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
14093
Active
1999-04-16
Complete
2018-04-19
2018-03-26
II
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Looking for Drug Master Files (DMF) for 14093 of Carbogen Amcis Bv

Looking for Drug Master Files (DMF) for 14093 of Carbogen Amcis Bv 1

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Carbogen Amcis Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is CALCITRIOL, with a corresponding US DMF Number 14093.

Remarkably, this DMF maintains an Active status since its submission on April 16, 1999, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 19, 2018, and payment made on March 26, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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