Orange Book product · Brand (NDA)

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

NICARDIPINE HYDROCHLORIDE

Brand (NDA)NDA 019734DISCN CHIESI

Nov 07, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 07, 2008
17 yr 10 mo ago
Today
Patent 7659291 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 10 mo
Patent 8455524 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 10 mo
Patent 7612102 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 7 mo
Patent 9364564 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 7 mo

Active ingredient

NICARDIPINE HYDROCHLORIDE

Strength

40MG/200ML (0.2MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 019734

Product number

005

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7659291	Apr 18, 2027	in 10 mo	U-1029
8455524	Apr 18, 2027	in 10 mo	U-1029
7612102	Dec 26, 2027	in 1 yr 7 mo	Product
9364564	Dec 26, 2027	in 1 yr 7 mo	Product