Azithromycin, unspecified form

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 2 NDC API, 41 Listed Suppliers, $ API Reference Price

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21 Drugs in Development

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6 Intermediates Suppliers

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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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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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PATENTS & EXCLUSIVITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 50710 / DOSAGE - FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML

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

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Preferred Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	NuCare Pharmaceuticals,Inc.	Preferred Pharmaceuticals Inc.	Proficient Rx LP	Quality Care Products LLC	Quality Care Products, LLC	RPK Pharmaceuticals, Inc.	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	REMEDYREPACK INC.	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	Rebel Distributors Corp.	Amneal Pharmaceuticals LLC	Lupin Pharmaceuticals,Inc.	Zydus Pharmaceuticals USA Inc.
ACACIA(5C5403N26O)
BANANA(4AJZ4765R9)
CHERRY(BUC5I9595W)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)
ETHYL VANILLIN(YC9ST449YJ)
FD&C RED NO. 40(WZB9127XOA)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
hydroxypropyl cellulose(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
MALTODEXTRIN(7CVR7L4A2D)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(SX01TZO3QZ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(B70850QPHR)
SUCROSE(C151H8M554)
TRIBASIC SODIUM PHOSPHATE(A752Q30A6X)
VANILLIN(CHI530446X)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Azithromycin, unspecified form