01 1Amphastar Pharmaceuticals
01 1SALMETEROL XINAFOATE, USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-06
Pay. Date : 2015-08-21
DMF Number : 29491
Submission : 2015-08-11
Status : Active
Type : II
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Amphastar Nanjing Pharmaceuticals Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SALMETEROL XINAFOATE, USP, with a corresponding US DMF Number 29491.
Remarkably, this DMF maintains an Active status since its submission on August 11, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 06, 2015, and payment made on August 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
