![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » LUPIN RECEIVES APPROVAL FOR GENERIC PRINZIDE
LUPIN RECEIVES APPROVAL FOR GENERIC PRINZIDE
October 2, 2006
Lupin Pharmaceuticals has announced that the FDA granted final approval for its abbreviated new drug application (ANDA) for lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg.
Lupin's drug is the AB-rated generic equivalent of Merck's Prinzide and is indicated for the treatment of hypertension. The product combines an ACE inhibitor, lisinopril, with a diuretic, hydrochlorothiazide.
This is Lupin's 16th ANDA approval and is the company's first FDA-approved combination drug.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct