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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019668
Company: VIATRIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDURA DOXAZOSIN MESYLATE EQ 1MG BASE TABLET;ORAL Prescription AB Yes Yes
CARDURA DOXAZOSIN MESYLATE EQ 2MG BASE TABLET;ORAL Prescription AB Yes No
CARDURA DOXAZOSIN MESYLATE EQ 4MG BASE TABLET;ORAL Prescription AB Yes No
CARDURA DOXAZOSIN MESYLATE EQ 8MG BASE TABLET;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/23/2021 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019668Orig1s032lbl.pdf
06/23/2021 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019668Orig1s032lbl.pdf
06/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf
11/06/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf
01/14/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf
07/10/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf
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