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01 1Kongo Chemical Co., Ltd.

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PharmaCompass

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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2014-06-27

Pay. Date : 2014-06-23

DMF Number : 3879

Submission : 1980-07-14

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 3879 of Kongo Chemical Co Ltd

Looking for Drug Master Files (DMF) for 3879 of Kongo Chemical Co Ltd 1

20

Kongo Chemical Co Ltd, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is DIPHENHYDRAMINE HCL USP, with a corresponding US DMF Number 3879.

Remarkably, this DMF maintains an Active status since its submission on July 14, 1980, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2014, and payment made on June 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II