Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204569
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BELSOMRA SUVOREXANT 5MG TABLET;ORAL Prescription None Yes No
BELSOMRA SUVOREXANT 10MG TABLET;ORAL Prescription None Yes No
BELSOMRA SUVOREXANT 15MG TABLET;ORAL Prescription None Yes No
BELSOMRA SUVOREXANT 20MG 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
08/13/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204569Orig1s005ltr.pdf
05/27/2016 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204569Orig1s004ltr.pdf
05/03/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/30/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf
11/07/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s001lbl.pdf
08/13/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204569s000lbledt.pdf

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