Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207997
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYDAPT MIDOSTAURIN 25MG CAPSULE;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
04/28/2017 ORIG-2 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207997Orig1Orig2s000TOC.cfm
04/28/2017 ORIG-1 Approval Efficacy PRIORITY; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2017 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf
04/28/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf

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