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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019488
Company: CHIESI

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CARDENE NICARDIPINE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
CARDENE NICARDIPINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No

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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