Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203412
Company: SLATE RUN PHARMA

Products on ANDA 203412

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 203412

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203412

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	203412	SLATE RUN PHARMA
ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050733	PFIZER