Nitrofurantoin, Monohydrate | 9175 | SUSPENSION;ORAL | 50MG/5ML

Nitrofurantoin Monohydrate

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ACTIVE PHARMA INGREDIENTS

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INTERMEDIATES

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FINISHED DOSAGE FORMULATIONS

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DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG, CAPSULE;ORAL - 75MG;25MG, SUSPENSION;ORAL - 25MG/5ML, SUSPENSION;ORAL - 50MG/5ML

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ANALYTICAL

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USFDA APPLICATION NUMBER - 9175 / DOSAGE - SUSPENSION;ORAL - 50MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)	NITROFURANTOIN	25mg in 5

Inactive Ingredients

Ingredient Name	Shionogi Inc.	Prasco Laboratories
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
GLYCERIN(PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)

Drug Product Composition: Nitrofurantoin, Monohydrate