Dolasetron Mesylate

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ACTIVE PHARMA INGREDIENTS

6 API Suppliers, 4 USDMF, 1 EU WC, 3 NDC API, 1 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 5 FDA Orange Book, 1 South Africa, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 50MG, INJECTABLE;INJECTION - 100MG/5ML (20MG/ML), INJECTABLE;INJECTION - 12.5MG/0.625ML (20MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 16 SPI Pharma, 5 DKSH, 3 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 10 Corel Pharma Chem, 1 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 3 Ideal Cures, 4 Ingredion Pharma Solutions, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 36 Fillers, Diluents & Binders, 20 Disintegrants & Superdisintegrants, 19 Direct Compression, 18 Solubilizers, 17 Chewable & Orodispersible Aids, 15 Controlled & Modified Release, 15 Taste Masking, 14 Topical, 13 Thickeners and Stabilizers, 11 Parenteral, 11 Granulation, 10 Film Formers & Plasticizers, 8 Lubricants & Glidants, 7 Co-Processed Excipients, 6 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Surfactant & Foaming Agents

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USFDA APPLICATION NUMBER - 20623 / DOSAGE - TABLET;ORAL - 100MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
dolasetron mesylate(UNII: U3C8E5BWKR) (dolasetron - UNII:82WI2L7Q6E)	dolasetron mesylate	100mg \| 50mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	sanofi-aventis U.S. LLC	Validus Pharmaceuticals LLC
CARNAUBA WAX(R12CBM0EIZ)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
hypromelloses(3NXW29V3WO)
lactose(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
magnesium stearate(70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
titanium dioxide(15FIX9V2JP)
white wax(7G1J5DA97F)

Setid 3df5f9f0 D374 425f 8a6d E58fbfb8ea04 Applno 20623 Form Tablet Oral Dosage 100mg - Drug Product Composition: Dolasetron Mesylate