Drug History: REMERON SOLTAB

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	REMERON SOLTAB
FDA Application No:	(NDA) 021208
Active Ingredient(s):	MIRTAZAPINE
Company:	ORGANON USA INC

Label History

View the label approved on July 31, 2007 for REMERON SOLTAB, (NDA) 021208

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
7/30/2007	010	Labeling Revision	Letter Label
1/12/2005	009	Labeling Revision	Letter Label
6/1/2004	008	Labeling Revision	Letter
11/14/2002	006	Labeling Revision	Letter
5/21/2002	005	Manufacturing Change or Addition
4/3/2002	004	Control Supplement
11/20/2001	003	Manufacturing Change or Addition
3/23/2001	002	Manufacturing Change or Addition
2/22/2001	001	Labeling Revision
1/12/2001	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents