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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207370
Company: AUROBINDO PHARMA LTD

Products on ANDA 207370

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 207370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/14/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207370

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	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	215772	STRIDES PHARMA
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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