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List of Drug Master Files (DMF) for 18971 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Divis Laboratories (1)

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01 TAMSULOSIN HYDROCHLORIDE (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
18971
Active
2005-11-25
Complete
2014-02-07
2014-02-03
II
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Looking for Drug Master Files (DMF) for 18971 of Divis Laboratories Ltd

Looking for Drug Master Files (DMF) for 18971 of Divis Laboratories Ltd 1

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Divis Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is TAMSULOSIN HYDROCHLORIDE, with a corresponding US DMF Number 18971.

Remarkably, this DMF maintains an Active status since its submission on November 25, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2014, and payment made on February 03, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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