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List of Drug Master Files (DMF) for 5722 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 ORPHENADRINE CITRATE 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
5722
Active
1985-02-22
Complete
2015-12-16
2013-07-05
II
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Looking for Drug Master Files (DMF) for 5722 of W R Grace And Co -conn

Looking for Drug Master Files (DMF) for 5722 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 ORPHENADRINE CITRATE USP, with a corresponding US DMF Number 5722.

Remarkably, this DMF maintains an Active status since its submission on February 22, 1985, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2015, and payment made on July 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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