Nicardipine Hydrochloride

NDA 78405, held by Sun Pharm. Nicardipine Hydrochloride.

As of Nov 13, 2026, NDA 78405 (Nicardipine Hydrochloride), held by Sun Pharm, was first approved by FDA on Nov 17, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 17, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 17, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nicardipine Hydrochloride25MG/10ML (2.5MG/ML) · injectable;injection	Nicardipine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 16, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Nov 17, 2009	Original application	Approved	None posted

Identifiers

Application: NDA 78405
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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