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Athena Athena

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List of Drug Master Files (DMF) for 4523 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 METOCLOPRAMIDE HYDROCHLORIDE (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
4523
Active
1982-05-03
Complete
2018-03-02
2018-01-12
II
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Looking for Drug Master Files (DMF) for 4523 of Cosma Spa

Looking for Drug Master Files (DMF) for 4523 of Cosma Spa 1

20

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

One of their notable products is METOCLOPRAMIDE HYDROCHLORIDE, with a corresponding US DMF Number 4523.

Remarkably, this DMF maintains an Active status since its submission on May 03, 1982, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2018, and payment made on January 12, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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