GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18025
Submission : 2005-01-27
Status : Active
Type : IV

Registration Number : 229MF40001
Registrant's Address : 925 West 1800 South Logan Utah 84321 USA
Initial Date of Registration : 2017-01-10
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 87126-014
Start Marketing Date : 2025-10-01
End Marketing Date : 2049-10-01
Dosage Form (Strength) : POWDER, FOR SOLUTION (1g/g)
Marketing Category : BULK INGREDIENT

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FINISHED DOSAGE FORMULATIONS
POLOXAMER 188
Route : ORAL
CAS :
UNII : LQA7B6G8JG
Potency Amount : 1.5
Potency Unit : MG

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POLOXAMER 188
Route : INTRAMUSCULAR
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.2
Potency Unit : %W/V

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POLOXAMER 188
Route : INTRAVENOUS
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.6
Potency Unit : %

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POLOXAMER 188
Route : INTRAVENOUS
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.22
Potency Unit : %

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POLOXAMER 188
Route : OPHTHALMIC
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.1
Potency Unit : %

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POLOXAMER 188
Route : OPHTHALMIC
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.1
Potency Unit : %

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POLOXAMER 188
Route : ORAL
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 10
Potency Unit : MG

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POLOXAMER 188
Route : ORAL
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 3.18
Potency Unit : MG

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POLOXAMER 188
Route : ORAL
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 4
Potency Unit : MG

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POLOXAMER 188
Route : ORAL
CAS : 691397-13-4
UNII : LQA7B6G8JG
Potency Amount : 0.25
Potency Unit : MG/1ML

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EXCIPIENTS BY APPLICATIONS
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Tablet
Grade : Parenteral, Oral, Topical
Category : Solubilizers
Application : Solubilizers
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Application : Solubilizers
Excipient Details : Poloxamer 188 provides better storage stability. It is used as solubilizers for liquid preparation & oral care products, matrix materials for ointment & gel.
Excipients Web Link
Dosage Form : Capsule, Emulsion, Gel, Solution, Tablet, Topical Film
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Dissolution enhancer, lubricant & wetting agent, drug solubilizer, plasticizer, thermoreversible gelling effect.
Pharmacopoeia Ref : Ph. Eur., USP-NF: Poloxamer 18...
Technical Specs : Not Available
Ingredient(s) : Poloxamer 188
Application : Thickeners and Stabilizers
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Dosage Form : Cream / Lotion / Ointment
Grade : Oral & Parenteral
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : Poloxamer 188 provides better storage stability. It is used as solubilizers for liquid preparation & oral care products, matrix materials for ointment & gel.
Excipients Web Link
Dosage Form : Capsule, Emulsion, Gel, Solution, Tablet, Topical Film
Grade : Not Available
Category : Thickeners and Stabilizers
Application : Thickeners and Stabilizers
Excipient Details : Dissolution enhancer, lubricant & wetting agent, drug solubilizer, plasticizer, thermoreversible gelling effect.
Pharmacopoeia Ref : Ph. Eur., USP-NF: Poloxamer 18...
Technical Specs : Not Available
Ingredient(s) : Poloxamer 188
Dosage Form : Capsule, Emulsion, Gel, Solution, Tablet, Topical Film
Grade : Not Available
Category : Granulation
Application : Granulation
Excipient Details : Dissolution enhancer, lubricant & wetting agent, drug solubilizer, plasticizer, thermoreversible gelling effect.
Pharmacopoeia Ref : Ph. Eur., USP-NF: Poloxamer 18...
Technical Specs : Not Available
Ingredient(s) : Poloxamer 188
Brand Name : Kolliphor P188 micro
Application : Granulation
Excipient Details : Dissolution enhancer, lubricant & wetting agent, Hydrophilic lubricant, effervescent tablets.
Pharmacopoeia Ref : Ph. Eur., USP-NF: Poloxamer 18...
Technical Specs : Not Available
Ingredient(s) : Poloxamer 188
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents
Application : Emulsifying Agents
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Application : Topical
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
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