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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218347
Company: ABBVIE

Medication Guide

Products on NDA 218347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RINVOQ LQ	UPADACITINIB	1MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218347s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218347Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218347Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675Orig1s028,218347Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211675Orig1s028,218347Orig1s005Correctedltr.pdf
03/26/2025	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s027,218347s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211675Orig1s027; 218347Orig1s002ltr.pdf

Labels for NDA 218347

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675Orig1s028,218347Orig1s005lbl.pdf
03/26/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s027,218347s002lbl.pdf
03/26/2025	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s027,218347s002lbl.pdf
04/26/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218347s000lbl.pdf

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