01 1American Pacific Corporation
01 1OSELTAMIVIR PHOSPHATE DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-23
Pay. Date : 2022-06-13
DMF Number : 35234
Submission : 2021-08-06
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 OSELTAMIVIR PHOSPHATE DRUG SUBSTANCE, with a corresponding US DMF Number 35234.
Remarkably, this DMF maintains an Active status since its submission on August 06, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2022, and payment made on June 13, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
