Azithromycin, unspecified form

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DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET, FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML, FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML, TABLET;ORAL - EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

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$ Xls

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USFDA APPLICATION NUMBER - 50733 / DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	100mg in 1

Inactive Ingredients

Ingredient Name	Mylan Institutional LLC	Sagent Pharmaceuticals	APOTEX CORP.	Athenex Pharmaceutical Division, LLC.	Baxter Healthcare Corporation	Cardinal Health	Fresenius Kabi USA, LLC
ANHYDROUS CITRIC ACID(XF417D3PSL)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
sodium hydroxide(55X04QC32I)

Drug Product Composition: Azithromycin, unspecified form