Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214460
Company: CHIMERIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMBEXA BRINCIDOFOVIR 10MG/ML SUSPENSION;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
06/04/2021 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214460Origs000,214461Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/03/2021 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s001,214461s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214460Orig1s001; 214461Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s001,214461s001lbl.pdf
06/04/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf

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