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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019488
Company: CHIESI

Products on NDA 019488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARDENE	NICARDIPINE HYDROCHLORIDE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
CARDENE	NICARDIPINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1988	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019488s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019488Orig1s010ltr.pdf
11/09/2001	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/20/1999	SUPPL-8	Labeling		Label is not available on this site.
12/30/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/17/1992	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/16/1990	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1990	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/1989	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/1989	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/18/1989	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019488

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019488s010lbl.pdf

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