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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218637
Company: KAMAT

Medication Guide

Products on NDA 218637

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RALDESY	TRAZODONE HYDROCHLORIDE	10MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218637

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218637s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218637Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218637Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2025	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218637s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218637Orig1s003ltr.pdf
11/13/2025	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218637Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/218637Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/218637Orig1s002ltr.pdf

Labels for NDA 218637

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218637Orig1s002lbl.pdf
06/24/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218637s003lbl.pdf
11/26/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218637s000lbl.pdf

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