01 1American Pacific Corporation
01 1LEVORPHANOL TARTRATE DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-17
Pay. Date : 2023-04-03
DMF Number : 34304
Submission : 2020-01-17
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 LEVORPHANOL TARTRATE DRUG SUBSTANCE, with a corresponding US DMF Number 34304.
Remarkably, this DMF maintains an Active status since its submission on January 17, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 17, 2023, and payment made on April 03, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
