Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215146
Company: CURIUM

Products on ANDA 215146

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215146

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DRAXIMAGE DTPA	TECHNETIUM TC-99M PENTETATE KIT	N/A	INJECTABLE;INJECTION	Prescription	Yes	AP	018511	JUBILANT
TECHNETIUM TC-99M PENTETATE KIT	TECHNETIUM TC-99M PENTETATE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	215146	CURIUM