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PharmaCompass

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BePharma
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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2013-08-05

Pay. Date : 2012-12-13

DMF Number : 16949

Submission : 2003-11-10

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 16949 of Olon Spa

Looking for Drug Master Files (DMF) for 16949 of Olon Spa 1

20

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

One of their notable products is HALOPERIDOL DECANOATE, with a corresponding US DMF Number 16949.

Remarkably, this DMF maintains an Active status since its submission on November 10, 2003, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 05, 2013, and payment made on December 13, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II