An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020114
Company: MYLAN SPCLT VIATRIS

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ASTELIN	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No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

Top