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PharmaCompass

01

Peptide Process CMC
Not Confirmed

01

Peptide Process CMC
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-02

Pay. Date : 2013-07-30

DMF Number : 12857

Submission : 1998-02-17

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 12857 of Olon Spa

Looking for Drug Master Files (DMF) for 12857 of Olon Spa 1

20

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

One of their notable products is ECONAZOLE NITRATE, with a corresponding US DMF Number 12857.

Remarkably, this DMF maintains an Active status since its submission on February 17, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 02, 2014, and payment made on July 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II