01 1Hetero Drugs
01 1ABACAVIR SULFATE (PROCESS-II), USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-27
Pay. Date : 2015-12-21
DMF Number : 29587
Submission : 2015-07-24
Status : Active
Type : II
20
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 ABACAVIR SULFATE (PROCESS-II), USP, with a corresponding US DMF Number 29587.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 27, 2016, and payment made on December 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
