01 1Sigmapharm Laboratories, LLC
01 1AMORPHOUS DOFETILIDE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-22
Pay. Date : 2014-06-09
DMF Number : 28301
Submission : 2014-06-05
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 AMORPHOUS DOFETILIDE, with a corresponding US DMF Number 28301.
Remarkably, this DMF maintains an Active status since its submission on June 05, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 22, 2014, and payment made on June 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
