01 1Hetero Drugs
01 1DORZOLAMIDE HYDROCHLORIDE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-22
Pay. Date : 2012-12-31
DMF Number : 26204
Submission : 2012-07-09
Status : Active
Type : II
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Hetero Drugs 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 DORZOLAMIDE HYDROCHLORIDE (PROCESS II), with a corresponding US DMF Number 26204.
Remarkably, this DMF maintains an Active status since its submission on July 09, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 22, 2013, and payment made on December 31, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
