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List of Drug Master Files (DMF) for 28915 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Lek Pharmaceuticals (1)

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01 TICAGRELOR (1)

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01 Slovenia (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28915
Active
2015-02-06
Complete
2015-06-05
2015-01-21
II
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Looking for Drug Master Files (DMF) for 28915 of Lek Pharmaceuticals Dd

Looking for Drug Master Files (DMF) for 28915 of Lek Pharmaceuticals Dd 1

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Lek Pharmaceuticals Dd, based in Slovenia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is TICAGRELOR, with a corresponding US DMF Number 28915.

Remarkably, this DMF maintains an Active status since its submission on February 06, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 05, 2015, and payment made on January 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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