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List of Drug Master Files (DMF) for 23631 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Apicore LLC (1)

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01 BEXAROTENE (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
23631
Active
2010-04-26
Complete
2015-08-07
2015-07-29
II
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Looking for Drug Master Files (DMF) for 23631 of Apicore Us Llc

Looking for Drug Master Files (DMF) for 23631 of Apicore Us Llc 1

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Apicore Us Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is BEXAROTENE, with a corresponding US DMF Number 23631.

Remarkably, this DMF maintains an Active status since its submission on April 26, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2015, and payment made on July 29, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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