Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020114
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTELIN AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription AB Yes Yes
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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ASTELIN

SPRAY, METERED;NASAL; EQ 0.125MG BASE/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTELIN AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020114 MYLAN SPECIALITY LP
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 208156 ALKEM LABS LTD
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 204660 AMNEAL PHARMS LLC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 077954 APOTEX INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 090176 BRECKENRIDGE PHARM
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 090423 SUN PHARMA GLOBAL
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 202609 UPSHER-SMITH LABS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 091444 WEST-WARD PHARMS INT
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 091409 ZYDUS PHARMS USA INC

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