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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213498
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PONVORY PONESIMOD 2MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 3MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 4MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 5MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 6MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 7MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 8MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 9MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 10MG TABLET;ORAL Prescription None Yes No
PONVORY PONESIMOD 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
03/18/2021 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213498Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2021 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/28/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf
10/28/2021 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf
03/18/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf
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