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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017680
Company: BRACCO

Products on NDA 017680

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHOSPHOTEC	TECHNETIUM TC-99M PYROPHOSPHATE KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017680

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1976	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-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017680s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017680Orig1s013ltr.pdf
12/14/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/21/1994	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/1988	SUPPL-10	Labeling		Label is not available on this site.
09/30/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/30/1982	SUPPL-8	Labeling		Label is not available on this site.
05/06/1983	SUPPL-6	Labeling		Label is not available on this site.
02/04/1982	SUPPL-5	Labeling		Label is not available on this site.
02/04/1982	SUPPL-4	Labeling		Label is not available on this site.
07/14/1977	SUPPL-3	Labeling		Label is not available on this site.
04/17/1978	SUPPL-2	Labeling		Label is not available on this site.
12/20/1976	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 017680

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017680s013lbl.pdf

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