01 1Hetero Drugs
01 1CYCLOBENZAPRINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-20
Pay. Date : 2014-02-13
DMF Number : 21392
Submission : 2008-03-05
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 CYCLOBENZAPRINE HYDROCHLORIDE, with a corresponding US DMF Number 21392.
Remarkably, this DMF maintains an Active status since its submission on March 05, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 20, 2014, and payment made on February 13, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
