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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213586
Company: TEVA

Products on NDA 213586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UZEDY	RISPERIDONE	50MG/0.14ML (50MG/0.14ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	75MG/0.21ML (75MG/0.21ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	100MG/0.28ML (100MG/0.28ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	125MG/0.35ML (125MG/0.35ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	150MG/0.42ML (150MG/0.42ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	200MG/0.56ML (200MG/0.56ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes
UZEDY	RISPERIDONE	250MG/0.7ML (250MG/0.7ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213586s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213586Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213586Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213586Orig1s008,s009ltr.pdf
10/10/2025	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213586Orig1s008,s009ltr.pdf
01/22/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213586Orig1s007ltr.pdf
11/01/2023	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213586Orig1s001ltr.pdf

Labels for NDA 213586

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/10/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s008s009lbl.pdf
10/10/2025	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s008s009lbl.pdf
01/22/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213586s007lbl.pdf
04/28/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213586s000lbl.pdf

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