01 1Sigmapharm Laboratories, LLC
01 1APIXABAN AMORPHOUS (6.58%)
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-08-15
DMF Number : 30774
Submission : 2016-08-10
Status : Active
Type : II
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Sigmapharm Laboratories Llc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is APIXABAN AMORPHOUS (6.58%), with a corresponding US DMF Number 30774.
Remarkably, this DMF maintains an Active status since its submission on August 10, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2016, and payment made on August 15, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
