01 1American Pacific Corporation
01 1TEMOZOLOMIDE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-12
Pay. Date : 2019-04-30
DMF Number : 28580
Submission : 2014-09-25
Status : Active
Type : II
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Ampac Fine Chemicals Llc, 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 TEMOZOLOMIDE, with a corresponding US DMF Number 28580.
Remarkably, this DMF maintains an Active status since its submission on September 25, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 12, 2019, and payment made on April 30, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
