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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020837
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INHALATION Discontinued None Yes No
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INHALATION Discontinued None Yes No
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INHALATION Discontinued None Yes No
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INHALATION Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/03/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020837s044lbl.pdf
03/31/2015 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbledt.pdf
01/22/2015 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf
03/31/2014 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020837s039lbl.pdf
09/20/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020837s038lbl.pdf
09/07/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf
01/30/2002 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf
03/25/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf
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