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List of Drug Master Files (DMF) for 4911 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Grace (1)

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01 PROCAINAMIDE HYDROCHLORIDE (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
4911
Active
1983-04-18
Complete
2013-06-19
2013-06-06
II
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Looking for Drug Master Files (DMF) for 4911 of W R Grace And Co -conn

Looking for Drug Master Files (DMF) for 4911 of W R Grace And Co -conn 1

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W R Grace And Co -conn, based in U.S.A, is a pharmaceutical company.

One of their notable products is PROCAINAMIDE HYDROCHLORIDE, with a corresponding US DMF Number 4911.

Remarkably, this DMF maintains an Active status since its submission on April 18, 1983, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 19, 2013, and payment made on June 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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