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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 : 2015-02-17

Pay. Date : 2013-09-12

DMF Number : 8973

Submission : 1991-02-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 8973 of Olon Spa

Looking for Drug Master Files (DMF) for 8973 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 IPRATROPIUM BROMIDE, with a corresponding US DMF Number 8973.

Remarkably, this DMF maintains an Active status since its submission on February 18, 1991, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 17, 2015, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II