Erythromycin Ethylsuccinate

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FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers, 42 FDA Orange Book, 3 Europe, 4 Australia, 9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

GRANULE;ORAL - EQ 200MG BASE/5ML, GRANULE;ORAL - EQ 400MG BASE/5ML

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USFDA APPLICATION NUMBER - 50207 / DOSAGE - GRANULE;ORAL - EQ 400MG BASE/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Erythromycin Ethylsuccinate(UNII: 1014KSJ86F) (Erythromycin - UNII:63937KV33D)	Erythromycin	200mg in 5

Inactive Ingredients

Ingredient Name	Par Pharmaceutical, Inc.	AbbVie Inc.	A-S Medication Solutions LLC
BANANA(4AJZ4765R9)
CARAMEL(T9D99G2B1R)
carboxymethylcellulose sodium(K679OBS311)
Citric Acid Monohydrate(2968PHW8QP)
FD&C Red No. 3(PN2ZH5LOQY)
magnesium aluminum silicate(6M3P64V0NC)
polysorbate 80(6OZP39ZG8H)
sodium citrate(1Q73Q2JULR)
SUCROSE(C151H8M554)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Erythromycin Ethylsuccinate