01 1NTP Radioisotopes Soc Ltd
01 1FISSION IODINE-131 (PRODUCED FROM LOW ENRICHED URANIUM(LEU) NORMAL PRODUCT
01 1South Africa
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-18
Pay. Date : 2013-06-10
DMF Number : 26619
Submission : 2012-10-29
Status : Active
Type : II
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Ntp Radioisotopes Soc Ltd, based in South Africa, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is FISSION IODINE-131 (PRODUCED FROM LOW ENRICHED URANIUM(LEU) NORMAL PRODUCT, with a corresponding US DMF Number 26619.
Remarkably, this DMF maintains an Active status since its submission on October 29, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 18, 2014, and payment made on June 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
