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List of Drug Master Files (DMF) for 22992 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Noramco (1)

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01 NALTREXONE DRUG SUBSTANCE (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

22992
Active
2009-07-28
Complete
2016-04-23
2016-04-07
II
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Looking for Drug Master Files (DMF) for 22992 of Noramco Llc

Looking for Drug Master Files (DMF) for 22992 of Noramco Llc 1

20

Noramco Llc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

One of their notable products is NALTREXONE DRUG SUBSTANCE, with a corresponding US DMF Number 22992.

Remarkably, this DMF maintains an Active status since its submission on July 28, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2016, and payment made on April 07, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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