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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215110
Company: ABBVIE

Products on NDA 215110

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAVYRET	GLECAPREVIR; PIBRENTASVIR	50MG/PACKET;20MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s000; 209394Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215110Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2025	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209394s019,215110s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209394Orig1s019;215110Orig1s005ltr.pdf
10/25/2023	SUPPL-3	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209394Orig1s016;215110Orig1s003ltr.pdf
09/28/2021	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s001;209394Orig1s014ltr.pdf

Labels for NDA 215110

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2025	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209394s019,215110s005lbl.pdf
10/25/2023	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf
09/28/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
09/28/2021	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
06/10/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf

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