Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020314
Company: CURIUM

Products on NDA 020314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCTREOSCAN	INDIUM IN-111 PENTETREOTIDE KIT	3mCi/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/1994	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020314Orig1s014ltr.pdf
02/09/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020314Orig1s012ltr.pdf
04/08/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/08/1994	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020314

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020314Orig1s012lbl.pdf
12/22/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020314S014lbl.pdf