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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018321
Company: CURIUM

Products on NDA 018321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNESCAN HDP	TECHNETIUM TC-99M OXIDRONATE KIT	N/A	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1981	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017538s023,018321s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017538Orig1s023,018321Orig1s026ltr.pdf
11/24/2025	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018321s025,017538s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/018321Orig1s025;017538Orig1s022ltr.pdf
03/31/2017	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018321Orig1s022ltr.pdf
06/17/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/14/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/08/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/14/1994	SUPPL-15	Labeling		Label is not available on this site.
09/30/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/05/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/10/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/28/1989	SUPPL-8	Efficacy-New Patient Population		Label is not available on this site.
02/03/1983	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/29/1996	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018321

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2025	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018321s025,017538s022lbl.pdf
05/22/2025	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017538s023,018321s026lbl.pdf
03/31/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf

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