01 1Sigmapharm Laboratories, LLC
01 1ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-08-13
DMF Number : 27300
Submission : 2013-08-08
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 ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX, with a corresponding US DMF Number 27300.
Remarkably, this DMF maintains an Active status since its submission on August 08, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 22, 2013, and payment made on August 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
