Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020256
Company: LANTHEUS MEDCL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEUROLITE TECHNETIUM TC-99M BICISATE KIT N/A INJECTABLE;INJECTION Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/23/1994 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/03/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
05/18/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/24/2000 SUPPL-7 Labeling

Label is not available on this site.
04/26/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
12/30/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
05/15/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/12/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
11/12/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
01/16/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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