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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215206
Company: ABBVIE

Products on NDA 215206

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QULIPTA	ATOGEPANT	10MG	TABLET;ORAL	Prescription	None	Yes	No
QULIPTA	ATOGEPANT	30MG	TABLET;ORAL	Prescription	None	Yes	No
QULIPTA	ATOGEPANT	60MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215206Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215206Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215206Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s013ltr..pdf
06/10/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s010;s012ltr.pdf
03/21/2025	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s011ltr.pdf
06/10/2025	SUPPL-10	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s010;s012ltr.pdf
04/17/2023	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215206s004lbl.pdf

Labels for NDA 215206

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s013lbl.pdf
06/10/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s010s012lbl.pdf
03/21/2025	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s011lbl.pdf
04/17/2023	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215206s004lbl.pdf
09/28/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215206Orig1s000lbl.pdf

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