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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065225
Company: PLIVA

Products on ANDA 065225

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065225

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
04/18/2020	SUPPL-33	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/18/2020	SUPPL-32	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/05/2017	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
09/05/2017	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
09/05/2017	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
03/20/2015	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/26/2013	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/18/2012	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/30/2010	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 065225

AZITHROMYCIN

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	215772	ACI
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	211791	ALEMBIC
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	207370	AUROBINDO PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	210000	BIONPHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065404	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	208250	CSPC OUYI
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065398	LUPIN LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065225	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	065211	SANDOZ
AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	209045	SUNSHINE
ZITHROMAX	AZITHROMYCIN	EQ 250MG BASE	TABLET;ORAL	Prescription	Yes	AB	050711	PFIZER

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