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Athena Athena

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List of Drug Master Files (DMF) for 4514 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 COSMA S.p.A (1)

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01 HYDROXYZINE PAMOATE (1)

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01 Italy (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
4514
Active
1982-04-16
Complete
2013-09-28
2013-09-24
II
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Looking for Drug Master Files (DMF) for 4514 of Cosma Spa

Looking for Drug Master Files (DMF) for 4514 of Cosma Spa 1

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Cosma Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROXYZINE PAMOATE, with a corresponding US DMF Number 4514.

Remarkably, this DMF maintains an Active status since its submission on April 16, 1982, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 28, 2013, and payment made on September 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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