01 1Wockhardt
01 1REGADENOSON (AMORPHOUS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-30
Pay. Date : 2015-03-31
DMF Number : 29185
Submission : 2015-03-31
Status : Active
Type : II
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Wockhardt Bio Ag, 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 REGADENOSON (AMORPHOUS), with a corresponding US DMF Number 29185.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 30, 2015, and payment made on March 31, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
