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List of Drug Master Files (DMF) for 32113 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 TRIENTINE HYDROCHLORIDE USP (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
32113
Active
2017-12-13
Complete
2018-01-12
2017-11-16
II
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Looking for Drug Master Files (DMF) for 32113 of Mylan Laboratories Ltd

Looking for Drug Master Files (DMF) for 32113 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 TRIENTINE HYDROCHLORIDE USP, with a corresponding US DMF Number 32113.

Remarkably, this DMF maintains an Active status since its submission on December 13, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 12, 2018, and payment made on November 16, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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