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List of Drug Master Files (DMF) for 28880 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Teva API (1)

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01 TICAGRELOR (1)

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01 Israel (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28880
Active
2015-01-21
Complete
2015-03-17
2014-12-09
II
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Looking for Drug Master Files (DMF) for 28880 of Teva Pharmaceutical Industries Ltd

Looking for Drug Master Files (DMF) for 28880 of Teva Pharmaceutical Industries Ltd 1

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Teva Pharmaceutical Industries Ltd, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Teva API has over 350 products in its portfolio and is the leading international supplier of APIs.

One of their notable products is TICAGRELOR, with a corresponding US DMF Number 28880.

Remarkably, this DMF maintains an Active status since its submission on January 21, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2015, and payment made on December 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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