Nitrofurantoin Monohydrate | 9175 | SUSPENSION;ORAL | 25MG/5ML

Nitrofurantoin, Monohydrate

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ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 34 USDMF, 16 CEP/COS, 7 EU WC, 28 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

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2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

131 FDF Dossiers, 72 FDA Orange Book, 22 Europe, 6 Canada, 4 Australia, 8 South Africa, 19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

RELATED EXCIPIENT COMPANIES

5 Rochem International Inc, 7 SPI Pharma, 10 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 1 Bioplus Life Sciences, 15 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 15 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 17 Finished Drug Prices

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27 APIs, 10 FDF Dossiers

REF. STANDARDS & IMPURITIES

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ANALYTICAL

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2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 9175 / DOSAGE - SUSPENSION;ORAL - 25MG/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	Caraco Pharmaceutical Laboratories, Ltd.	Shionogi Inc.	Prasco Laboratories
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
FRUIT(C2AIY4ERZC)
GLYCERIN(PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
METHYLPARABEN(A2I8C7HI9T)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
SUCRALOSE(96K6UQ3ZD4)
WATER(059QF0KO0R)

Drug Product Composition: Nitrofurantoin Monohydrate