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


FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FINISHED DOSAGE FORMULATIONS
Drug : KALETRA
Dosage Form : TABLET; ORAL
Application Number : 21906
Country : US
Patented : No
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug : VIEKIRA PAK (COPACKAGED)
Dosage Form : TABLET; ORAL
Application Number : 206619
Country : US
Patented : Yes
Drug : NORVIR
Dosage Form : TABLET; ORAL
Application Number : 22417
Country : US
Patented : No
Drug : NOCTIVA
Dosage Form : SPRAY, METERED; NASAL
Application Number : 201656
Country : US
Patented : Yes

Drug : ARISTADA
Dosage Form : SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Application Number : 207533
Country : US
Patented : Yes

Drug : RITONAVIR
Dosage Form : TABLET; ORAL
Application Number : 206614
Country : US
Patented : No

Drug : RITONAVIR
Dosage Form : TABLET; ORAL
Application Number : 202573
Country : US
Patented : No

Drug : CLOBETASOL PROPIONATE
Dosage Form : AEROSOL, FOAM; TOPICAL
Application Number : 211450
Country : US
Patented : No

ACETAMINOPHEN; ASPIRIN; CAFFEINE
Drug : EXCEDRIN (MIGRAINE RELIEF)
Dosage Form : TABLET; ORAL
Application Number : 20802
Country : US
Patented : No

Drug : RITONAVIR
Dosage Form : TABLET; ORAL
Application Number : 204587
Country : US
Patented : No

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SORBITAN MONOLAURATE
Route : INTRAMUSCULAR
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 1.23
Potency Unit : %

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : OPHTHALMIC
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0.08
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 2.5
Potency Unit : MG/5ML

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 66.7
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SORBITAN MONOLAURATE
Route : ORAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 83.9
Potency Unit : MG

Portfolio PDF
Product Web Link
Virtual Booth
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SORBITAN MONOLAURATE
Route : TOPICAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 4.74
Potency Unit : %W/W

Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
SORBITAN MONOLAURATE
Route : TOPICAL
CAS : 1338-39-2
UNII : 6W9PS8B71J
Potency Amount : 4.74
Potency Unit : %W/W

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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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