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List of Drug Master Files (DMF) for 19526 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Curia (1)

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01 OLOPATADINE HYDROCHLORIDE (PROCESS I) (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
19526
Active
2006-06-14
Complete
2016-03-02
2016-02-12
II
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Looking for Drug Master Files (DMF) for 19526 of Curia Spain Sau

Looking for Drug Master Files (DMF) for 19526 of Curia Spain Sau 1

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

They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

One of their notable products is OLOPATADINE HYDROCHLORIDE (PROCESS I), with a corresponding US DMF Number 19526.

Remarkably, this DMF maintains an Active status since its submission on June 14, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2016, and payment made on February 12, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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