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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065399
Company: LUPIN LTD

Products on ANDA 065399

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 065399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2015	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
07/14/2022	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/26/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/01/2020	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/01/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/01/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/27/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065399

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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