Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208684
Company: PTC THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMFLAZA DEFLAZACORT 6MG TABLET;ORAL Prescription None Yes No
EMFLAZA DEFLAZACORT 18MG TABLET;ORAL Prescription None Yes No
EMFLAZA DEFLAZACORT 30MG TABLET;ORAL Prescription None Yes No
EMFLAZA DEFLAZACORT 36MG TABLET;ORAL 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
02/09/2017 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208684Orig1s000,208685Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208684,208685Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf

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