Treats hypertension. NDA 212895, held by Cspc Ouyi. Levamlodipine Maleate.
As of Nov 14, 2026, NDA 212895 (Conjupri), held by Cspc Ouyi, was first approved by FDA on Dec 19, 2019, with 0 approved supplements and 0 published complete response letters.
CONJUPRI is calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension CONJUPRI is indicated for the treatment of hypertension in adults and patients 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2019 | Original applicationTYPE 2/3 · Standard review | Approved |
| ConjupriEQ 1.25MG BASE · tablet;oral | Levamlodipine Maleate | DiscontinuedReference drug |
| ConjupriEQ 2.5MG BASE · tablet;oral | Levamlodipine Maleate | DiscontinuedReference drug |
| ConjupriEQ 5MG BASE · tablet;oral | Levamlodipine Maleate | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
