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01 1Laboratorio Chimico Internazionale Spa

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PharmaCompass

01

BePharma
Not Confirmed

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BePharma
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-21

Pay. Date : 2013-09-13

DMF Number : 4416

Submission : 1982-01-23

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 4416 of Olon Spa

Looking for Drug Master Files (DMF) for 4416 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 CARISOPRODOL, with a corresponding US DMF Number 4416.

Remarkably, this DMF maintains an Active status since its submission on January 23, 1982, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2013, and payment made on September 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II