Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021012
Company: CIS BIO INTL SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEO TECT KIT TECHNETIUM TC-99M DEPREOTIDE N/A INJECTABLE;INJECTION Discontinued None No No
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English