Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204441
Company: OTSUKA PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JYNARQUE TOLVAPTAN 15MG TABLET;ORAL Prescription None Yes No
JYNARQUE TOLVAPTAN 30MG TABLET;ORAL Prescription None Yes No
JYNARQUE TOLVAPTAN 45MG TABLET;ORAL Prescription None Yes Yes
JYNARQUE TOLVAPTAN 60MG TABLET;ORAL Prescription None Yes No
JYNARQUE TOLVAPTAN 90MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/23/2018 ORIG-1 Approval PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2018 SUPPL-2 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441s002ltr.pdf
07/30/2018 SUPPL-1 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s001Ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/01/2018 SUPPL-2 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf
04/23/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf

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