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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018482
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCARDIA NIFEDIPINE 10MG CAPSULE;ORAL Prescription AB Yes Yes
PROCARDIA NIFEDIPINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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
01/09/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf
07/25/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf
09/27/2011 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf
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