Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050724
Company: LEADIANT BIOSCI INC

Products on NDA 050724

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABELCET	AMPHOTERICIN B	5MG/ML	INJECTABLE, LIPID COMPLEX;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050724

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1995	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/06/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/29/1999	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
08/20/1999	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/10/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/11/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/13/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/20/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/18/1996	SUPPL-2	Efficacy-New Indication		Label is not available on this site.