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Athena Athena

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List of Drug Master Files (DMF) for 17781 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Atul Limited (1)

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01 DAPSONE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
17781
Active
2004-10-28
Complete
2013-08-12
2013-02-26
II
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Looking for Drug Master Files (DMF) for 17781 of Atul Ltd

Looking for Drug Master Files (DMF) for 17781 of Atul Ltd 1

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Atul Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

One of their notable products is DAPSONE USP, with a corresponding US DMF Number 17781.

Remarkably, this DMF maintains an Active status since its submission on October 28, 2004, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 12, 2013, and payment made on February 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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