01 1Sri Krishna Pharmaceuticals
01 1SODIUM PHENYLBUTYRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-09
Pay. Date : 2019-07-03
DMF Number : 19569
Submission : 2006-06-30
Status : Active
Type : II
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Sri Krishna Pharmaceuticals 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 SODIUM PHENYLBUTYRATE USP, with a corresponding US DMF Number 19569.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2019, and payment made on July 03, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
