01 1Amphastar Pharmaceuticals
01 1IPRATROPIUM BROMIDE USP
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2022-11-04
DMF Number : 31036
Submission : 2017-11-28
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 IPRATROPIUM BROMIDE USP, with a corresponding US DMF Number 31036.
Remarkably, this DMF maintains an Active status since its submission on November 28, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 16, 2023, and payment made on November 04, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
