Drug History: AMIODARONE HYDROCHLORIDE

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Label and Approval History

Drug Name:	AMIODARONE HYDROCHLORIDE
FDA Application No:	(ANDA) 074739
Active Ingredient(s):	AMIODARONE HYDROCHLORIDE
Company:	TEVA PHARMS

Label History

View the label approved on November 30, 1998 for AMIODARONE HYDROCHLORIDE, (ANDA) 074739

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
5/24/2002	013	Labeling
4/11/2001	012	Packaging Addition
4/11/2001	011	Facility Addition
12/7/2000	010	Facility Addition
12/7/2000	009	Facility Addition
12/7/2000	008	Facility Addition
2/29/2000	007	Labeling
10/26/1999	005	Chemistry
3/23/1999	004	Chemistry
9/2/1999	003	Labeling
9/2/1999	002	Chemistry
9/2/1999	001	Chemistry
11/30/1998	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents