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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021726
Company: UCB INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIRAVAM ALPRAZOLAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/16/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf
02/06/2006 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021726s006lbl.pdf
01/19/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021726lbl.pdf
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