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List of Drug Master Files (DMF) for 29491 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 SALMETEROL XINAFOATE, 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
29491
Active
2015-08-11
Complete
2015-11-06
2015-08-21
II
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Looking for Drug Master Files (DMF) for 29491 of Amphastar Nanjing Pharmaceuticals Inc

Looking for Drug Master Files (DMF) for 29491 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 SALMETEROL XINAFOATE, USP, with a corresponding US DMF Number 29491.

Remarkably, this DMF maintains an Active status since its submission on August 11, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 06, 2015, and payment made on August 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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