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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217036
Company: HAINAN POLY

Products on ANDA 217036

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 217036

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217036

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	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

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

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