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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211675
Company: ABBVIE

Medication Guide

Products on NDA 211675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RINVOQ	UPADACITINIB	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
RINVOQ	UPADACITINIB	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
RINVOQ	UPADACITINIB	45MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211675

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
05/18/2023	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s015ltr.pdf
04/10/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s012ltr.pdf
10/21/2022	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s010ltr.pdf
12/02/2021	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675orig1s008ltr.pdf
03/16/2022	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s007ltr.pdf
12/14/2021	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf
01/14/2022	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s004ltr.pdf
04/29/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s003ltr.pdf
12/14/2021	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf
07/10/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	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

Labels for NDA 211675

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2023	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s015lbl.pdf
04/10/2023	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf
04/10/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf
10/21/2022	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf
04/29/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf
03/16/2022	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf
01/14/2022	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf
12/14/2021	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/14/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/14/2021	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf
12/02/2021	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf
12/02/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf
07/10/2020	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf
07/10/2020	SUPPL-1	Labeling-Package Insert	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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