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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020005
Company: CHIESI

Products on NDA 020005

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARDENE SR	NICARDIPINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
CARDENE SR	NICARDIPINE HYDROCHLORIDE	45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
CARDENE SR	NICARDIPINE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020005

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/1992	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/29/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020005Orig1s014ltr.pdf
07/30/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/2001	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/29/1999	SUPPL-5	Labeling		Label is not available on this site.
01/07/1997	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/22/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/04/1993	SUPPL-2	Labeling		Label is not available on this site.
11/20/1992	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020005

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf

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