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Athena Athena

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List of Drug Master Files (DMF) for 29035 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Apotex Pharmachem (1)

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01 DEXLANSOPRAZOLE ANHYDRATE (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
29035
Active
2015-03-30
Complete
2015-06-11
2015-03-19
II
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Looking for Drug Master Files (DMF) for 29035 of Apotex Pharmachem Inc

Looking for Drug Master Files (DMF) for 29035 of Apotex Pharmachem Inc 1

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Apotex Pharmachem Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DEXLANSOPRAZOLE ANHYDRATE, with a corresponding US DMF Number 29035.

Remarkably, this DMF maintains an Active status since its submission on March 30, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 11, 2015, and payment made on March 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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