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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022051
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLONASE SENSIMIST ALLERGY RELIEF FLUTICASONE FUROATE 0.0275MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014lbl.pdf
04/05/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022051Orig1s014ltr.pdf
08/02/2016 SUPPL-13 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Orig1s013lbl.pdf
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