Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208798
Company: TEVA PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.055MG/INH POWDER;INHALATION Prescription None Yes No
ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.113MG/INH POWDER;INHALATION Prescription None Yes No
ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.232MG/INH POWDER;INHALATION Prescription None 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
01/27/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208798s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208798Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208798Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208798s000lbl.pdf

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