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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 021726

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NIRAVAM	ALPRAZOLAM	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
NIRAVAM	ALPRAZOLAM	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
NIRAVAM	ALPRAZOLAM	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
NIRAVAM	ALPRAZOLAM	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021726

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

Labels for NDA 021726

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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