01 1Amphastar Pharmaceuticals
01 1MEDROXYPROGESTERONE ACETATE, USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-14
Pay. Date : 2021-09-30
DMF Number : 32282
Submission : 2018-02-08
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 MEDROXYPROGESTERONE ACETATE, USP, with a corresponding US DMF Number 32282.
Remarkably, this DMF maintains an Active status since its submission on February 08, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 14, 2022, and payment made on September 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
