GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25438
Submission : 2011-10-25
Status : Active
Type : IV


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FINISHED DOSAGE FORMULATIONS
SORBITAN MONOLAURATE
Route : INTRAMUSCULAR
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 1.23
Potency Unit : %

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SORBITAN MONOLAURATE
Route : OPHTHALMIC
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0.08
Potency Unit : MG

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 2.5
Potency Unit : MG/5ML

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 66.7
Potency Unit : MG

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SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 83.9
Potency Unit : MG

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SORBITAN MONOLAURATE
Route : TOPICAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 4.74
Potency Unit : %W/W

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SORBITAN MONOLAURATE
Route : TOPICAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 4.74
Potency Unit : %W/W

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EXCIPIENTS BY APPLICATIONS
Application : Emulsifying Agents
Excipient Details : They are used as surfactants or emulsifying agents in the preparation of emulsions, creams, and ointments for pharmaceutical and cosmetic use.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, FDA...
Technical Specs : Not Available
Ingredient(s) : Sorbitan Monolaurate
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Spray, Syrup
Grade : Topical, Oral
Category : Emulsifying Agents
Brand Name : MONTANE 20 PHA PREMIUM
Application : Emulsifying Agents
Excipient Details : Non-ionic lipophilic surfactant, emulsifier.
Pharmacopoeia Ref : Ph.Eur, USP-NF
Technical Specs : HLB: 9; EXCiPACT
Ingredient(s) : Sorbitan Monolaurate
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Oral, Parenteral, Topical
Category : Emulsifying Agents
Brand Name : MONTANE 20 PHA PREMIUM
Application : Emulsifying Agents
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Lipophilic Surfactant; Emulsifier (w/o emulsions)
Ingredient(s) : Sorbitan Monolaurate
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