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Setid Ed3ef3f8 8cb7 40db 9d75 E728ee607760 Applno 208399 Form Emulsion Intravenous Dosage Eq 166 5mg Base 92 5ml Eq 1 8mg Base Ml - Drug Product Composition: Rolapitant HCl

Rolapitant HCl

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ACTIVE PHARMA INGREDIENTS

3 API Suppliers, 1 USDMF, 2 NDC API, 1 Listed Suppliers

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 2 FDA Orange Book, 1 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 90MG BASE, EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 3 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 3 Kirsch Pharma, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 21 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 1 Finar, 11 Gangwal Chemicals, 2 Ideal Cures, 3 Ingredion Pharma Solutions, 13 Kerry, 2 Keval Exports, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 16 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 23 Solubilizers, 21 Direct Compression, 20 Coating Systems & Additives, 20 Granulation, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 17 Parenteral, 15 Controlled & Modified Release, 13 Topical, 12 Lubricants & Glidants, 11 Co-Processed Excipients, 7 Emulsifying Agents, 7 Film Formers & Plasticizers, 6 Chewable & Orodispersible Aids, 6 Taste Masking, 3 Rheology Modifiers, 3 API Stability Enhancers, 3 Surfactant & Foaming Agents, 2 Coloring Agents

DIGITAL CONTENT

11 News #PharmaBuzz

11 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

1 US Medicaid Prescriptions

MARKET PLACE

5 APIs

5 APIs

PATENTS & EXCLUSIVITIES

13 US Patents

13 US Patents

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USFDA APPLICATION NUMBER - 208399 / DOSAGE - EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROLAPITANT HYDROCHLORIDE(UNII: 57O5S1QSAQ) (rolapitant - UNII:NLE429IZUC)	rolapitant	90mg
rolapitant(UNII: NLE429IZUC) (rolapitant - UNII:NLE429IZUC)	rolapitant	1.8mg in 1

Inactive Ingredients

Ingredient Name	Tesaro, Inc.
croscarmellose sodium(M28OL1HH48)
FD&C Blue NO. 2(L06K8R7DQK)
hydrochloric acid(QTT17582CB)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
medium-chain triglycerides(C9H2L21V7U)
microcrystalline cellulose(OP1R32D61U)
peg-15 hydroxystearates(71YMM1X75O)
polyethylene glycol, unspecified(3WJQ0SDW1A)
polysorbate 80(6OZP39ZG8H)
polyvinyl alcohol, unspecified(532B59J990)
povidone, unspecified(FZ989GH94E)
silicon dioxide(ETJ7Z6XBU4)
sodium chloride(451W47IQ8X)
sodium hydroxide(55X04QC32I)
sodium phosphate, dibasic, anhydrous(22ADO53M6F)
soybean oil(241ATL177A)
starch, corn(O8232NY3SJ)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
water(059QF0KO0R)

Setid Ed3ef3f8 8cb7 40db 9d75 E728ee607760 Applno 208399 Form Emulsion Intravenous Dosage Eq 166 5mg Base 92 5ml Eq 1 8mg Base Ml - Drug Product Composition: Rolapitant HCl

Rolapitant HCl

Rolapitant HCl

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

3 API Suppliers

1 USDMF

2 NDC API

1 Listed Suppliers

DEVELOPMENTS

7 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers

2 FDA Orange Book

1 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 90MG BASE

EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

3 DKSH

1 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

3 Kirsch Pharma

8 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

21 BASF

5 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

1 Finar

11 Gangwal Chemicals

2 Ideal Cures

3 Ingredion Pharma Solutions

13 Kerry

2 Keval Exports

10 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

16 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders

23 Solubilizers

21 Direct Compression

20 Coating Systems & Additives

20 Granulation

18 Disintegrants & Superdisintegrants

17 Thickeners and Stabilizers

17 Parenteral

15 Controlled & Modified Release

13 Topical

12 Lubricants & Glidants

11 Co-Processed Excipients

7 Emulsifying Agents

7 Film Formers & Plasticizers

6 Chewable & Orodispersible Aids

6 Taste Masking

3 Rheology Modifiers

3 API Stability Enhancers

3 Surfactant & Foaming Agents

2 Coloring Agents

DIGITAL CONTENT