Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065209
Company: SANDOZ

Products on ANDA 065209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2021	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
01/08/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
02/01/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/01/2019	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
01/05/2017	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
05/14/2015	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
06/25/2013	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/09/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/12/2012	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/01/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/19/2010	SUPPL-10	Labeling-Patient Package Insert		Label is not available on this site.
06/30/2008	SUPPL-7	Labeling		Label is not available on this site.
01/29/2008	SUPPL-6	Labeling		Label is not available on this site.
06/20/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065209

AZITHROMYCIN

TABLET;ORAL; EQ 600MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	211793	ALEMBIC
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	209999	BIONPHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	065302	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	207566	CSPC OUYI
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	065400	LUPIN LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	065218	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	065209	SANDOZ
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	209043	SUNSHINE
AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET;ORAL	Prescription	No	AB	211068	YUNG SHIN PHARM