Ondansetron Hydrochloride

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ACTIVE PHARMA INGREDIENTS

63 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 7 EU WC, 14 KDMF, 23 NDC API, 30 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers, 102 FDA Orange Book, 40 Europe, 39 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INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 5 Rochem International Inc, 19 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 9 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 7 Kirsch Pharma, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 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, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 37 Direct Compression, 32 Thickeners and Stabilizers, 32 Disintegrants & Superdisintegrants, 29 Parenteral, 29 Granulation, 29 Taste Masking, 25 Controlled & Modified Release, 22 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 17 Topical, 16 Solubilizers, 13 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

20 APIs, 2 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 20103 / DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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	GlaxoSmithKline LLC	Novartis Pharmaceuticals Corporation
ANHYDROUS CITRIC ACID(XF417D3PSL)
ASPARTAME(Z0H242BBR1)
FERRIC OXIDE YELLOW(EX438O2MRT)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHYLPARABEN SODIUM(CR6K9C2NHK)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PROPYLPARABEN SODIUM(625NNB0G9N)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
WATER(059QF0KO0R)

Setid C7d61d98 Fe86 4340 9b86 47eb92acaa0e Applno 20103 Form Tablet Oral Dosage Eq 24mg Base - Drug Product Composition: Ondansetron Hydrochloride