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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210884
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOSYMRA SUMATRIPTAN 10MG/SPRAY SPRAY;NASAL 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
01/25/2019 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210884s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210884Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210884Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210884s000lbledt.pdf
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