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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213378
Company: ALKERMES INC

Medication Guide

Products on NDA 213378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	5MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	10MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	No
LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	15MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	No
LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	20MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213378

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2021	ORIG-2	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213378Orig1s000, Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213378Orig1Orig2s000TOC.cfm
05/28/2021	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213378Orig1s000, Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213378Orig1Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2024	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213378s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213378Orig1s007ltr.pdf
09/25/2023	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213378Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213378Orig1s005ltr.pdf

Labels for NDA 213378

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2024	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213378s007lbl.pdf
01/30/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213378s007lbl.pdf
09/25/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213378Orig1s005lbl.pdf
09/25/2023	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213378Orig1s005lbl.pdf
09/25/2023	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213378Orig1s005lbl.pdf
05/28/2021	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf
05/28/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf

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