Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208984
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELZENTRY MARAVIROC 20MG/ML SOLUTION;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
11/04/2016 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208984Orig1s000,022128Orig1s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208984Orig1s000,022128Orig1s017TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2018 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022128Orig1s018,208984Orig1s001Ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf
11/04/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf

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