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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020887
Company: CIS BIO INTL SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACUTECT TECHNETIUM TC-99M APCITIDE 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
09/14/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20887ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20887.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/2001 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
09/14/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20887lbl.pdf
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