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List of Drug Master Files (DMF) for 32289 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Chattem Chemicals, Inc (1)

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01 LISDEXAETAMINE DIMESYLATE (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
32289
Active
2018-05-18
Complete
2019-07-02
2018-05-22
II
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Looking for Drug Master Files (DMF) for 32289 of Chattem Chemicals Inc

Looking for Drug Master Files (DMF) for 32289 of Chattem Chemicals Inc 1

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Chattem Chemicals Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LISDEXAETAMINE DIMESYLATE, with a corresponding US DMF Number 32289.

Remarkably, this DMF maintains an Active status since its submission on May 18, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 02, 2019, and payment made on May 22, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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