Ondansetron Hydrochloride

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 18 CEP/COS, 5 JDMF, 13 EU WC, 11 KDMF, 21 NDC API, 28 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

169 FDF Dossiers, 102 FDA Orange Book, 36 Canada, 10 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML

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1 Minakem, 5 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 9 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 32 Disintegrants & Superdisintegrants, 31 Controlled & Modified Release, 29 Thickeners and Stabilizers, 27 Taste Masking, 24 Granulation, 24 Parenteral, 23 Lubricants & Glidants, 20 Film Formers & Plasticizers, 19 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 15 Solubilizers, 15 Topical, 9 Empty Capsules, 7 API Stability Enhancers, 7 Emulsifying Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Finished Drug Prices

MARKET PLACE

16 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP, 1 Others

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USFDA APPLICATION NUMBER - 20605 / DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)	ONDANSETRON	4mg \| 8mg \| 4mg in 5
ONDANSETRON(UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS)	ONDANSETRON	4mg \| 8mg

Inactive Ingredients

Ingredient Name	Apotex Corp	AvPAK	GlaxoSmithKline Inc	GlaxoSmithKline LLC	NuCare Pharmaceuticals, Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
ASPARTAME(Z0H242BBR1)
FERRIC OXIDE YELLOW(EX438O2MRT)
FRUCTOSE(6YSS42VSEV)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(8136Y38GY5)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHYLPARABEN SODIUM(CR6K9C2NHK)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PROPYLPARABEN SODIUM(625NNB0G9N)
SACCHARIN SODIUM(SB8ZUX40TY)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
WATER(059QF0KO0R)

Drug Product Composition: Ondansetron Hydrochloride