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 : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18025
Submission : 2005-01-27
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : AVAPRO
Dosage Form : TABLET; ORAL
Application Number : 20757
Country : US
Patented : No
Drug : METHYLPHENIDATE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 213473
Country : US
Patented : No
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Drug : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Application Number : 204206
Country : US
Patented : No
Drug : SIROLIMUS
Dosage Form : TABLET; ORAL
Application Number : 201578
Country : US
Patented : No
Drug : TERIL
Dosage Form : SUSPENSION; ORAL
Application Number : 76729
Country : US
Patented : No
Drug : CARBAMAZEPINE
Dosage Form : TABLET, CHEWABLE; ORAL
Application Number : 75687
Country : US
Patented : No
Drug : FLO-PRED
Dosage Form : SUSPENSION; ORAL
Application Number : 22067
Country : US
Patented : Yes
Drug : DEFERASIROX
Dosage Form : TABLET; ORAL
Application Number : 211824
Country : US
Patented : No
Drug : ITRACONAZOLE
Dosage Form : CAPSULE; ORAL
Application Number : 208591
Country : US
Patented : No
Drug : ESOMEPRAZOLE MAGNESIUM
Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL
Application Number : 208333
Country : US
Patented : No
POLOXAMER 188
Route : ORAL
CAS :
UNII : LQA7B6G8JG
Potency Amount : 1.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : INTRAMUSCULAR
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.2
Potency Unit : %W/V
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : INTRAVENOUS
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.6
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : INTRAVENOUS
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.22
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : OPHTHALMIC
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.1
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : OPHTHALMIC
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.1
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : ORAL
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 10
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : ORAL
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 3.18
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : ORAL
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 4
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
POLOXAMER 188
Route : ORAL
CAS : 691397134
UNII : LQA7B6G8JG
Potency Amount : 0.25
Potency Unit : MG/1ML
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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
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
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