Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018124
Company: SUN PHARM INDS INC

Products on NDA 18124

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIS-MDP	TECHNETIUM TC-99M MEDRONATE KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	No	No

Labels for NDA 018124

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017972s017,018124s032,019039s022lbl.pdf
04/19/2005	SUPPL-13	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf