Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019488
Company: CHIESI USA INC
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CARDENE NICARDIPINE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
CARDENE NICARDIPINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No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
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.

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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