Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065246
Company: PLIVA

Products on ANDA 065246

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065246s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2023	SUPPL-30	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/13/2020	SUPPL-26	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/13/2020	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/28/2017	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
06/28/2017	SUPPL-23	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/28/2017	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/28/2017	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/11/2013	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/28/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/18/2012	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/22/2009	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065246

AZITHROMYCIN

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	205666	AMNEAL
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	207531	EPIC PHARMA LLC
AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217036	HAINAN POLY
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	211147	ZYDUS LIFESCIENCES
ZITHROMAX	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050710	PFIZER

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	205666	AMNEAL
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	207531	EPIC PHARMA LLC
AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	217036	HAINAN POLY
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	211147	ZYDUS LIFESCIENCES
ZITHROMAX	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050710	PFIZER