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List of Drug Master Files (DMF) for 15986 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 BUTALBITAL, 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
15986
Active
2002-05-24
Complete
2014-04-18
2014-04-11
II
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Looking for Drug Master Files (DMF) for 15986 of Chattem Chemicals Inc

Looking for Drug Master Files (DMF) for 15986 of Chattem Chemicals Inc 1

20

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 BUTALBITAL, USP, with a corresponding US DMF Number 15986.

Remarkably, this DMF maintains an Active status since its submission on May 24, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2014, and payment made on April 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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