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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016515
Company: CURIUM

Products on NDA 016515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM IODIDE I 131	SODIUM IODIDE I-131	3.5-150mCi/VIAL	SOLUTION;ORAL	Discontinued	None	Yes	No
SODIUM IODIDE I 131	SODIUM IODIDE I-131	0.8-100mCi	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1971	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
02/06/2018	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016515s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016515Orig1s016ltr.pdf
10/20/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016515Orig1s013ltr.pdf
03/20/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016515Orig1s012ltr.pdf
02/03/2012	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016515s010ltr.pdf
07/11/1983	SUPPL-7	Labeling		Label is not available on this site.
06/07/1988	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
07/27/1977	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/27/1977	SUPPL-3	Labeling		Label is not available on this site.
10/27/1977	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/1976	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 016515

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016515s016lbl.pdf
10/20/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf
03/20/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf
02/03/2012	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf

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