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List of Drug Master Files (DMF) for 19745 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Hetero Drugs (1)

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01 THALIDOMIDE 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
19745
Active
2006-09-11
Complete
2014-01-22
2013-12-06
II
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Looking for Drug Master Files (DMF) for 19745 of Hetero Labs Ltd

Looking for Drug Master Files (DMF) for 19745 of Hetero Labs Ltd 1

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Hetero Labs 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 THALIDOMIDE USP, with a corresponding US DMF Number 19745.

Remarkably, this DMF maintains an Active status since its submission on September 11, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2014, and payment made on December 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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