Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014399
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB Yes Yes
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/09/2018 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014399s071lbl.pdf
07/02/2014 SUPPL-69 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf
11/19/2012 SUPPL-67 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-66 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
10/26/2009 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf
07/30/2007 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf
04/11/2006 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf
01/12/2005 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf

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