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List of Drug Master Files (DMF) for 28812 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Viatris (1)

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01 TICAGRELOR (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
28812
Active
2014-12-10
Complete
2015-02-25
2014-11-25
II
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Looking for Drug Master Files (DMF) for 28812 of Mylan Laboratories Ltd

Looking for Drug Master Files (DMF) for 28812 of Mylan Laboratories Ltd 1

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

One of their notable products is TICAGRELOR, with a corresponding US DMF Number 28812.

Remarkably, this DMF maintains an Active status since its submission on December 10, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2015, and payment made on November 25, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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