Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020219
Company: NOVARTIS

Products on NDA 020219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIVOSTIN	LEVOCABASTINE HYDROCHLORIDE	EQ 0.05% BASE	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	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
12/26/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/23/1999	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1998	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/30/1997	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/1996	SUPPL-4	Labeling		Label is not available on this site.
06/10/1996	SUPPL-3	Efficacy-New Dosing Regimen		Label is not available on this site.
03/23/1995	SUPPL-2	Labeling		Label is not available on this site.
10/24/1994	SUPPL-1	Labeling		Label is not available on this site.