01 1J.B.Chemicals & Pharmaceuticals
01 1DICLOFENAC SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 12469
Submission : 1997-04-14
Status : Active
Type : II
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Unique Chemicals, 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 DICLOFENAC SODIUM USP, with a corresponding US DMF Number 12469.
Remarkably, this DMF maintains an Active status since its submission on April 14, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 14, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
