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List of Drug Master Files (DMF) for 30995 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 HYDROMORPHONE HYDROCHLORIDE, 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
30995
Active
2016-11-23
Complete
2017-05-23
2016-11-25
II
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Looking for Drug Master Files (DMF) for 30995 of Chattem Chemicals Inc

Looking for Drug Master Files (DMF) for 30995 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 HYDROMORPHONE HYDROCHLORIDE, USP, with a corresponding US DMF Number 30995.

Remarkably, this DMF maintains an Active status since its submission on November 23, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 23, 2017, and payment made on November 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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