01 1Teva API
01 1LAMOTRIGINE
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-09
DMF Number : 15924
Submission : 2002-04-04
Status : Active
Type : II
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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 LAMOTRIGINE, with a corresponding US DMF Number 15924.
Remarkably, this DMF maintains an Active status since its submission on April 04, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 30, 2012, and payment made on November 09, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
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