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List of Drug Master Files (DMF) for 15442 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Chemische Fabrik Berg (1)

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01 PHENTERMINE HYDROCHLORIDE USP (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
15442
Active
2001-05-14
Complete
2014-08-27
2014-08-20
II
Moehs Chemische Fabrik Berg

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Looking for Drug Master Files (DMF) for 15442 of Chemische Fabrik Berg Gmbh

Looking for Drug Master Files (DMF) for 15442 of Chemische Fabrik Berg Gmbh 1

20

Chemische Fabrik Berg Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is PHENTERMINE HYDROCHLORIDE USP, with a corresponding US DMF Number 15442.

Remarkably, this DMF maintains an Active status since its submission on May 14, 2001, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2014, and payment made on August 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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