01 1Sandoz B2B
01 1AMOXICILLIN TRIHYDRATE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-23
Pay. Date : 2023-05-22
DMF Number : 38086
Submission : 2023-06-02
Status : Active
Type : II
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Sandoz Gmbh, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for A global leader in antibiotics.
One of their notable products is AMOXICILLIN TRIHYDRATE, with a corresponding US DMF Number 38086.
Remarkably, this DMF maintains an Active status since its submission on June 02, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2023, and payment made on May 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
