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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065488
Company: CHARTWELL RX

Products on ANDA 065488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065488

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
09/23/2025	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/11/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/24/2017	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/24/2017	SUPPL-2	Labeling-Package Insert	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/065488Orig1s002.pdf
05/25/2016	SUPPL-1		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/065488Orig1s001.pdf

Therapeutic Equivalents for ANDA 065488

AZITHROMYCIN

FOR SUSPENSION;ORAL; EQ 100MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	209201	AUROBINDO PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065488	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	207531	EPIC PHARMA LLC
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065246	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217036	ZHEJIANG POLY PHARM
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211147	ZYDUS LIFESCIENCES
ZITHROMAX	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050710	PFIZER

FOR SUSPENSION;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	209201	AUROBINDO PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065488	CHARTWELL RX
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	207531	EPIC PHARMA LLC
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065246	PLIVA
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217036	ZHEJIANG POLY PHARM
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211147	ZYDUS LIFESCIENCES
ZITHROMAX	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050710	PFIZER

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