Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020114
Company: MYLAN SPCLT VIATRIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTELIN AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED;NASAL Discontinued None Yes No
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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