Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211793
Company: ALEMBIC

Products on ANDA 211793

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 211793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2020	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.
11/22/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211793

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