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List of Drug Master Files (DMF) for 4684 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Bayer AG (1)

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01 ESTRADIOL (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
4684
Active
1982-10-13
Complete
2013-01-28
2013-01-08
II
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Looking for Drug Master Files (DMF) for 4684 of Bayer Ag

Looking for Drug Master Files (DMF) for 4684 of Bayer Ag 1

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Bayer Ag, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTRADIOL, with a corresponding US DMF Number 4684.

Remarkably, this DMF maintains an Active status since its submission on October 13, 1982, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 28, 2013, and payment made on January 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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