01 1Chemische Fabrik Berg
01 1HYDROXYZINE HYDROCHLORIDE
01 1Germany
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2023-12-01
DMF Number : 35249
Submission : 2023-12-05
Status : Active
Type : II
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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 HYDROXYZINE HYDROCHLORIDE, with a corresponding US DMF Number 35249.
Remarkably, this DMF maintains an Active status since its submission on December 05, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 12, 2024, and payment made on December 01, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
