01 1American Pacific Corporation
01 1CARMUSTINE (BCNU)
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-16
Pay. Date : 2016-04-18
DMF Number : 13169
Submission : 1998-09-01
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 CARMUSTINE (BCNU), with a corresponding US DMF Number 13169.
Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2016, and payment made on April 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
