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List of Drug Master Files (DMF) for 31036 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Amphastar Pharmaceuticals (1)

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01 IPRATROPIUM BROMIDE USP (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
31036
Active
2017-11-28
Complete
2023-03-16
2022-11-04
II
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Looking for Drug Master Files (DMF) for 31036 of Amphastar Nanjing Pharmaceuticals Inc

Looking for Drug Master Files (DMF) for 31036 of Amphastar Nanjing Pharmaceuticals Inc 1

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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

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