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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017084
Company: CURIUM

Products on NDA 017084

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHOSPHOCOL P32	CHROMIC PHOSPHATE P-32	5mCi/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017084

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1974	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
05/22/2009	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017084s017ltr.pdf
08/29/2008	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017084s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017084s016ltr.pdf
08/28/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/22/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1994	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/10/1990	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/31/1983	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/1982	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/24/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/23/1977	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/27/1977	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/29/1977	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/29/1977	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 017084

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2009	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017084s017lbl.pdf
08/29/2008	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017084s016lbl.pdf

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