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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020114
Company: NORVIUM BIOSCIENCE

Products on NDA 020114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASTELIN	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020114Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2018	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020114s028lbl.pdf
10/23/2014	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020114Orig1s026ltr.pdf
03/13/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
01/20/2012	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020114s023ltr.pdf
08/10/2007	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020114s017ltr.pdf
02/17/2006	SUPPL-14	Efficacy-New Dosing Regimen		Label is not available on this site.
06/27/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/2000	SUPPL-6	Efficacy-New Patient Population	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S06ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin.cfm
05/30/2000	SUPPL-5	Efficacy-New Indication	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S5LTR.PDF
10/13/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/16/1999	SUPPL-2	Labeling		Label is not available on this site.
09/29/1997	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020114

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2018	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020114s028lbl.pdf
10/23/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf
01/20/2012	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf

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