Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019981
Company: CURIUM

Products on NDA 019981

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/1991	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/27/2026	SUPPL-11	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019981s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019981Orig1s011ltr.pdf
09/09/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/18/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/08/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/23/1998	SUPPL-3	Labeling		Label is not available on this site.
09/30/1993	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1992	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019981

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2026	SUPPL-11	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019981s011lbl.pdf