Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021012
Company: CIS BIO INTL SA

Products on NDA 021012

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEO TECT KIT	TECHNETIUM TC-99M DEPREOTIDE	N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021012

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21012_Neotect.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2004	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21012s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21012s007ltr.pdf
01/30/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/26/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021012

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2004	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21012s007lbl.pdf
08/03/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21012lbl.pdf