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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019684
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCARDIA XL NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
PROCARDIA XL NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
PROCARDIA XL NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/09/2021 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf
01/09/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf
05/06/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf
07/25/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf
09/27/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf
10/04/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf
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