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Athena Athena

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List of Drug Master Files (DMF) for 7809 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 FDC Limited (1)

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01 ALBUTEROL SULFATE USP (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
7809
Active
1988-12-12
Complete
2014-06-05
2014-05-28
II
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Looking for Drug Master Files (DMF) for 7809 of Fdc Ltd

Looking for Drug Master Files (DMF) for 7809 of Fdc Ltd 1

20

Fdc 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 ALBUTEROL SULFATE USP, with a corresponding US DMF Number 7809.

Remarkably, this DMF maintains an Active status since its submission on December 12, 1988, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 05, 2014, and payment made on May 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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