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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090923
Company: SUN PHARM INDS LTD

Products on ANDA 090923

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090923

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2013	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
04/11/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/11/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/11/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/01/2017	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/19/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090923

AZITHROMYCIN

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203294	EUGIA PHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065179	FRESENIUS KABI USA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065501	GLAND PHARMA LTD
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065500	HOSPIRA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065511	HOSPIRA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203412	SLATE RUN PHARMA
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090923	SUN PHARM INDS LTD
ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050733	PFIZER

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