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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211765
Company: ABBVIE

Products on NDA 211765

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UBRELVY	UBROGEPANT	50MG	TABLET;ORAL	Prescription	None	Yes	No
UBRELVY	UBROGEPANT	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211765

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211765Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211765Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211765Orig1s013ltr.pdf
06/05/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211765Orig1s012ltr.pdf
02/17/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211765s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211765Orig1s007ltr.pdf
03/03/2021	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211765Orig1s002ltr.pdf

Labels for NDA 211765

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s012lbl.pdf
03/21/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s013lbl.pdf
02/17/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211765s007lbl.pdf
12/23/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf

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