Drugs@FDA: FDA Approved Drug Products

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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NIRAVAM ALPRAZOLAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
NIRAVAM ALPRAZOLAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/19/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021726lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021726ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021726s000_NiravamTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2012 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/16/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021726s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021726s008ltr.pdf
02/06/2006 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021726s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021726s006ltr.pdf
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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