Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214835
Company: LABS FARMS ROVI SA

Products on NDA 214835

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISVAN	RISPERIDONE	75MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Discontinued	None	Yes	No
RISVAN	RISPERIDONE	100MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214835

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214835s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214835Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214835Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2025	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214835s001s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214835Orig1s001,s004ltr.pdf
01/22/2025	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214835Orig1s001,s004ltr.pdf

Labels for NDA 214835

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214835s001s004lbl.pdf
03/29/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214835s000lbl.pdf