Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020005
Company: CHIESI USA INC
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CARDENE SR NICARDIPINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
CARDENE SR NICARDIPINE HYDROCHLORIDE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
CARDENE SR NICARDIPINE HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
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.

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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