01 15N Plus Lubeck GmbH
01 1BISMUTH SUBCITRATE POTASSIUM
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-09
Pay. Date : 2022-02-22
DMF Number : 30295
Submission : 2017-09-06
Status : Active
Type : II
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5n Plus Lubeck Gmbh, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is BISMUTH SUBCITRATE POTASSIUM, with a corresponding US DMF Number 30295.
Remarkably, this DMF maintains an Active status since its submission on September 06, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2022, and payment made on February 22, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
