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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065179
Company: FRESENIUS KABI USA

Products on ANDA 065179

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 065179

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2005	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
05/31/2022	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/24/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/24/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/27/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/14/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/01/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/01/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065179

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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