03375_FLUKA

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 19 USDMF, 4 CEP/COS, 7 JDMF, 2 EU WC, 4 KDMF, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1596 FDF Dossiers, 617 FDA Orange Book, 573 Europe, 155 Canada, 2 Australia, 192 South Africa, 57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;450MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;450MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;450MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;450MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;225MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML, TABLET, EXTENDED RELEASE;ORAL - 10MEQ, TABLET, EXTENDED RELEASE;ORAL - 8MEQ, SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;900MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;900MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;900MG/100ML, INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;900MG/100ML, FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT, EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML), INJECTABLE;INJECTION - 1.49GM/100ML, INJECTABLE;INJECTION - 14.9MG/ML, INJECTABLE;INJECTION - 2.24GM/100ML, INJECTABLE;INJECTION - 2.98GM/100ML, INJECTABLE;INJECTION - 29.8MG/ML, INJECTABLE;INJECTION - 745MG/100ML, INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML), SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML, FOR SOLUTION;ORAL - 10MEQ, FOR SOLUTION;ORAL - 20MEQ, FOR SOLUTION;ORAL - 40MEQ, TABLET;ORAL - 0.225GM;0.188GM;1.479GM, INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 2MEQ/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 1 Evonik, 10 Rochem International Inc, 22 SPI Pharma, 13 DKSH, 2 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 2 Kewpie Corporation, 10 Nanjing Well Pharmaceutical, 2 Shanghai Minbiotech, 2 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 16 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 38 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 3 Ideal Cures, 4 Ingredion Pharma Solutions, 16 Kerry, 2 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 2 Lubrizol Life Science Health, 19 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 10 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 33 Roquette, 5 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 1 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 40 Direct Compression, 39 Taste Masking, 39 Thickeners and Stabilizers, 37 Topical, 37 Coating Systems & Additives, 35 Disintegrants & Superdisintegrants, 34 Granulation, 32 Parenteral, 30 Lubricants & Glidants, 27 Controlled & Modified Release, 26 Solubilizers, 25 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 15 Co-Processed Excipients, 14 Emulsifying Agents, 8 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Rheology Modifiers, 4 API Stability Enhancers, 3 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 99 News #PharmaBuzz

GLOBAL SALES INFORMATION

74 US Medicaid Prescriptions, 304 Regulatory FDF Prices

MARKET PLACE

36 APIs, 14 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

15 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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USFDA APPLICATION NUMBER - 213135 / DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479GM

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE ANHYDROUS	2.7g
POTASSIUM CHLORIDE(UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	2.25g
SODIUM SULFATE(UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	17.75g

Inactive Ingredients

Ingredient Name	Braintree Laboratories, Inc.
ETHYLENE GLYCOL(FC72KVT52F)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(23ZQ42JZZH)
SODIUM CAPRYLATE(9XTM81VK2B)

Drug Product Composition: 03375_FLUKA

03375_FLUKA

03375_FLUKA

ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers

19 USDMF

4 CEP/COS

7 JDMF

2 EU WC

4 KDMF

20 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1596 FDF Dossiers

617 FDA Orange Book

573 Europe

155 Canada

2 Australia

192 South Africa

57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

CAPSULE, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;450MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;450MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;450MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;450MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;225MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

TABLET, EXTENDED RELEASE;ORAL - 10MEQ

TABLET, EXTENDED RELEASE;ORAL - 8MEQ

SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;900MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;900MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;900MG/100ML

INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;900MG/100ML

FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

INJECTABLE;INJECTION - 1.49GM/100ML

INJECTABLE;INJECTION - 14.9MG/ML

INJECTABLE;INJECTION - 2.24GM/100ML

INJECTABLE;INJECTION - 2.98GM/100ML

INJECTABLE;INJECTION - 29.8MG/ML

INJECTABLE;INJECTION - 745MG/100ML

INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

FOR SOLUTION;ORAL - 10MEQ

FOR SOLUTION;ORAL - 20MEQ

FOR SOLUTION;ORAL - 40MEQ

TABLET;ORAL - 0.225GM;0.188GM;1.479GM

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

CAPSULE, EXTENDED RELEASE;ORAL - 10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 10MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 20MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 8MEQ Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;225MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;225MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons