Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211675
Company: ABBVIE INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RINVOQ UPADACITINIB 15MG TABLET, EXTENDED RELEASE;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
08/16/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211675Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211675Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211675Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/10/2020 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf
07/10/2020 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf
08/16/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf

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