01 1Zydus Lifesciences
01 1PROMETHAZINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-04
Pay. Date : 2025-07-28
DMF Number : 19840
Submission : 2006-10-09
Status : Active
Type : II
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Zydus Lifesciences 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 PROMETHAZINE HYDROCHLORIDE USP, with a corresponding US DMF Number 19840.
Remarkably, this DMF maintains an Active status since its submission on October 09, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2025, and payment made on July 28, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
