Application 020005

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDENE SR	NICARDIPINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CARDENE SR	NICARDIPINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	45MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CARDENE SR	NICARDIPINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68151-0089	Cardene	nicardipine hydrochloride	Carilion Materials Management	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
45171	SUPPL	2016-08-29
45067	SUPPL	2016-08-26