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List of Drug Master Files (DMF) for 5196 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 BENZONATATE 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
5196
Active
1983-12-13
Complete
2013-06-06
2013-05-23
II
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Looking for Drug Master Files (DMF) for 5196 of W R Grace And Co -conn

Looking for Drug Master Files (DMF) for 5196 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 BENZONATATE USP, with a corresponding US DMF Number 5196.

Remarkably, this DMF maintains an Active status since its submission on December 13, 1983, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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