Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018675
Company: NOVARTIS

Products on NDA 018675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAVIST	CLEMASTINE FUMARATE	EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1985	ORIG-1	Approval	Type 3 - New Dosage Form	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
02/11/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/14/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1994	SUPPL-6	Labeling		Label is not available on this site.
07/21/1994	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1987	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.