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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065193
Company: TEVA

Products on ANDA 065193

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065193

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
05/17/2020	SUPPL-24	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/17/2020	SUPPL-22	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/05/2017	SUPPL-21	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/05/2017	SUPPL-20	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/05/2017	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/12/2015	SUPPL-16	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/21/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/18/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/13/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/13/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/28/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/26/2008	SUPPL-5	Labeling		Label is not available on this site.
09/27/2007	SUPPL-3	Labeling		Label is not available on this site.
06/19/2007	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 065193

AZITHROMYCIN

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	215773	ACI
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	211792	ALEMBIC
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	207398	AUROBINDO PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	210001	BIONPHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065405	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	208249	CSPC OUYI
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065399	LUPIN LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065223	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065212	SANDOZ
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	209044	SUNSHINE
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065193	TEVA
ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	Yes	AB	050784	PFIZER

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