01 1Hetero Drugs
01 1ABACAVIR SULFATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 22196
Submission : 2008-11-17
Status : Active
Type : II
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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, with a corresponding US DMF Number 22196.
Remarkably, this DMF maintains an Active status since its submission on November 17, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 15, 2013, and payment made on January 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
