Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020256

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020256

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.