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Setid E37ae7a6 7074 4744 8d56 C85d7e4ad587 Applno 22259 Form Cream Topical Dosage 4 - Drug Product Composition: Efudix

Efudix

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 15 USDMF, 4 CEP/COS, 2 JDMF, 12 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

467 Drugs in Development

467 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

179 FDF Dossiers, 69 FDA Orange Book, 59 Europe, 6 Canada, 20 Australia, 11 South Africa, 14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;TOPICAL - 2%, SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%, CREAM;TOPICAL - 4%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 SPI Pharma, 10 DKSH, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 Kirsch Pharma, 5 Actylis, 1 Ashland, 10 BASF, 1 BioSpectra, 1 CD Formulation, 1 Clariant, 2 Corel Pharma Chem, 1 Esteem Industries, 2 Finar, 6 Gangwal Chemicals, 1 Kerry, 2 Lubrizol Life Science Health, 3 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pluviaendo, 4 Roquette, 9 Seppic, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

30 Topical, 23 Solubilizers, 17 Parenteral, 15 Thickeners and Stabilizers, 12 Emulsifying Agents, 11 Film Formers & Plasticizers, 10 Fillers, Diluents & Binders, 8 Surfactant & Foaming Agents, 8 Coating Systems & Additives, 4 Direct Compression, 4 Lubricants & Glidants, 3 Rheology Modifiers, 2 Controlled & Modified Release, 2 Granulation, 1 Co-Processed Excipients, 1 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 45 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 24 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

16 APIs, 15 FDF Dossiers

REF. STANDARDS & IMPURITIES

6 EDQM, 1 USP, 16 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 22259 / DOSAGE - CREAM;TOPICAL - 4%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FLUOROURACIL(UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)	FLUOROURACIL	40mg in 1

Inactive Ingredients

Ingredient Name	Pierre Fabre Pharmaceuticals, Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CETYL ALCOHOL(936JST6JCN)
GLYCERIN(PDC6A3C0OX)
GLYCERYL MONOSTEARATE(230OU9XXE4)
ISOPROPYL MYRISTATE(0RE8K4LNJS)
METHYL GLUCETH-10(N0MWT4C7WH)
METHYLPARABEN(A2I8C7HI9T)
PEANUT OIL(5TL50QU0W4)
POLYOXYL 100 STEARATE(YD01N1999R)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM HYDROXIDE(55X04QC32I)
STEARIC ACID(4ELV7Z65AP)
STEARYL ALCOHOL(2KR89I4H1Y)
WATER(059QF0KO0R)

Setid E37ae7a6 7074 4744 8d56 C85d7e4ad587 Applno 22259 Form Cream Topical Dosage 4 - Drug Product Composition: Efudix

Efudix

Efudix

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

43 API Suppliers

15 USDMF

4 CEP/COS

2 JDMF

12 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

467 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

179 FDF Dossiers

69 FDA Orange Book

59 Europe

6 Canada

20 Australia

11 South Africa

14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;TOPICAL - 2%

SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 0.5%

CREAM;TOPICAL - 4%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 SPI Pharma

10 DKSH

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 Kirsch Pharma

5 Actylis

1 Ashland

10 BASF

1 BioSpectra

1 CD Formulation

1 Clariant

2 Corel Pharma Chem

1 Esteem Industries

2 Finar

6 Gangwal Chemicals

1 Kerry

2 Lubrizol Life Science Health

3 Microlex e.U

2 Nanjing Bold Chemical

1 Pluviaendo

4 Roquette

9 Seppic

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

30 Topical

23 Solubilizers

17 Parenteral

15 Thickeners and Stabilizers

12 Emulsifying Agents

11 Film Formers & Plasticizers

10 Fillers, Diluents & Binders

8 Surfactant & Foaming Agents

8 Coating Systems & Additives

4 Direct Compression

4 Lubricants & Glidants

3 Rheology Modifiers

2 Controlled & Modified Release

2 Granulation

1 Co-Processed Excipients

1 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

45 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions

24 Regulatory FDF Prices

SOLUTION;TOPICAL - 5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons